Trial Outcomes & Findings for Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy (NCT NCT00307164)
NCT ID: NCT00307164
Last Updated: 2021-11-04
Results Overview
Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
167 participants
Primary outcome timeframe
Baseline and Week 48
Results posted on
2021-11-04
Participant Flow
Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between October 5, 2006 (date first subject was randomized) and January 7, 2008 (date last subject was randomized).
A total of 167 subjects were randomized, and results are reported for 165 eligible participants; two subjects never started study medication and were excluded from all analyses. The subjects were stratified by antiretroviral therapy use, stavudine (d4T) or zidovudine (AZT/ZDV).
Participant milestones
| Measure |
NucleomaxX
Participants received NucleomaxX for uridine through week 48
|
Placebo
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
82
|
|
Overall Study
COMPLETED
|
68
|
68
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
Reasons for withdrawal
| Measure |
NucleomaxX
Participants received NucleomaxX for uridine through week 48
|
Placebo
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Severe debilitation, unable to continue
|
1
|
0
|
|
Overall Study
Subject/parent not able to get to clinic
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
8
|
|
Overall Study
Not compliant with requirements
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
Baseline Characteristics
Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy
Baseline characteristics by cohort
| Measure |
NucleomaxX
n=83 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=82 Participants
Participants received NucleomaxX placebo through week 48
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 7.78 • n=99 Participants
|
48.4 years
STANDARD_DEVIATION 6.46 • n=107 Participants
|
48.4 years
STANDARD_DEVIATION 7.13 • n=206 Participants
|
|
Age, Customized
30-39 Years
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Customized
40-49 Years
|
38 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Age, Customized
50-59 Years
|
28 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Age, Customized
60-69 Years
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
50 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic (Regardless of Race)
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian, Pacific Islander
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American, Alaskan Native
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other (More than One Race)
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=99 Participants
|
81 participants
n=107 Participants
|
162 participants
n=206 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Antiretroviral Therapy Used (Stratification)
AZT-Containing
|
63 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
|
Antiretroviral Therapy Used (Stratification)
d4T-Containing
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
HIV-1 RNA (copies/mL) Category
<=50 Copies
|
70 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
HIV-1 RNA (copies/mL) Category
>50 Copies
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
CD4+ Count (NucleomaxX sample size (N)=80, Placebo N=80)
|
506 Cells/mm^3
n=99 Participants
|
504 Cells/mm^3
n=107 Participants
|
506 Cells/mm^3
n=206 Participants
|
|
Limb fat
|
3149 Grams
n=99 Participants
|
2995 Grams
n=107 Participants
|
3037 Grams
n=206 Participants
|
|
Trunk fat
|
8175 Grams
n=99 Participants
|
7795 Grams
n=107 Participants
|
8114 Grams
n=206 Participants
|
|
Fasting lactate (NucleomaxX N=76, Placebo N=75)
|
1.3 mmol/L
n=99 Participants
|
1.2 mmol/L
n=107 Participants
|
1.3 mmol/L
n=206 Participants
|
|
Fasting glucose (NucleomaxX N=82, Placebo N=82)
|
90 mg/dL
n=99 Participants
|
87 mg/dL
n=107 Participants
|
89 mg/dL
n=206 Participants
|
|
Fasting total cholesterol (NucleomaxX N=82, Placebo N=81)
|
194 mg/dL
n=99 Participants
|
190 mg/dL
n=107 Participants
|
193 mg/dL
n=206 Participants
|
|
Fasting high-density lipoprotein (HDL) (NucleomaxX N=82, Placebo N=80)
|
39 mg/dL
n=99 Participants
|
37 mg/dL
n=107 Participants
|
38 mg/dL
n=206 Participants
|
|
Fasting non-high-density lipoprotein (non-HDL) (NucleomaxX N=77, Placebo N=69)
|
139 mg/dL
n=99 Participants
|
145 mg/dL
n=107 Participants
|
143 mg/dL
n=206 Participants
|
|
Fasting low-density lipoprotein (LDL) (NucleomaxX N=73, Placebo N=67)
|
107 mg/dL
n=99 Participants
|
110 mg/dL
n=107 Participants
|
109 mg/dL
n=206 Participants
|
|
Fasting triglycerides (NucleomaxX N=82, Placebo N=81)
|
161 mg/dL
n=99 Participants
|
165 mg/dL
n=107 Participants
|
164 mg/dL
n=206 Participants
|
|
Hemoglobin
|
14.9 g/dL
n=99 Participants
|
15.0 g/dL
n=107 Participants
|
14.9 g/dL
n=206 Participants
|
|
Leukocytes
|
5.6 cells*10^3/L
n=99 Participants
|
5.5 cells*10^3/L
n=107 Participants
|
5.5 cells*10^3/L
n=206 Participants
|
|
Creatine kinase (NucleomaxX N=80, Placebo N=82)
|
125 IU/L
n=99 Participants
|
142 IU/L
n=107 Participants
|
134 IU/L
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 48Population: Intention to treat analysis with last observation carried forward (LOCF) if week 48 limb fat data was missing and post-baseline limb fat was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).
Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.
Outcome measures
| Measure |
NucleomaxX
n=75 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=69 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in Limb Fat (g) From Baseline
|
74 grams
Interval -206.0 to 344.0
|
110 grams
Interval -202.0 to 393.0
|
SECONDARY outcome
Timeframe: Through Week 48Population: As-treated analysis with subjects stratified based on ART (d4T or AZT).
Time to safety events (grade 3 \[Severe\] or 4 \[life-threatening\] sign/symptom or laboratory-based abnormality that is at least one grade higher than baseline) from study entry
Outcome measures
| Measure |
NucleomaxX
n=83 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=82 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities)
|
47.1 weeks
Interval 17.6 to 48.7
|
47.9 weeks
Interval 34.1 to 48.7
|
SECONDARY outcome
Timeframe: Through Week 48Population: Intention to treat analysis based on all subjects who started study treatment.
Number of eligible subjects who discontinued study medication during the study period.
Outcome measures
| Measure |
NucleomaxX
n=83 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=82 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Number of Subjects Discontinuing Study Medication
|
34 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Intention to treat analysis with LOCF if week 24 limb fat data was missing and post-baseline before week 24 limb fat observation was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).
Limb fat was measured at baseline and visit week 24 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 24 (week 24 - baseline) was estimated for the treatment groups.
Outcome measures
| Measure |
NucleomaxX
n=75 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=66 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in Limb Fat From Baseline (Week 24 - Baseline)
|
54 grams
Interval -117.0 to 315.0
|
7 grams
Interval -202.0 to 238.0
|
SECONDARY outcome
Timeframe: At Week 48Population: Intention to treat analysis with all randomized subjects. Reduced sample size was due to missing data at week 48.
Outcome measures
| Measure |
NucleomaxX
n=67 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=69 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
HIV-1 RNA Level
<=50 copies/ml
|
59 Participants
|
54 Participants
|
|
HIV-1 RNA Level
>50 copies/ml
|
8 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Intention to treat analysis with LOCF if week 48 CD4+ data was missing and post-baseline data was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).
Outcome measures
| Measure |
NucleomaxX
n=80 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=80 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in CD4+ Count From Baseline (Week 48 - Baseline)
|
33 cells/mm3
Interval -44.0 to 90.0
|
28 cells/mm3
Interval -43.0 to 108.0
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Intention to treat analysis with LOCF if week 48 fasting lactate was missing and post-baseline fasting lactate was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).
Outcome measures
| Measure |
NucleomaxX
n=67 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=62 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in Fasting Lactate From Baseline (Week 48 - Baseline)
|
0.2 mmol/L
Interval -0.2 to 0.6
|
0.1 mmol/L
Interval -0.2 to 0.4
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Intention to treat analysis with LOCF if week 48 fasting glucose was missing and post-baseline fasting glucose was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).
Outcome measures
| Measure |
NucleomaxX
n=78 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=78 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in Fasting Glucose From Baseline (Week 48 - Baseline)
|
2 mg/dL
Interval -6.0 to 9.0
|
4 mg/dL
Interval -5.0 to 11.0
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Intention to treat analysis with LOCF if week 48 fasting total cholesterol was missing and post-baseline fasting total cholesterol was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).
Outcome measures
| Measure |
NucleomaxX
n=77 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=75 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline)
|
2 mg/dL
Interval -15.0 to 22.0
|
-6 mg/dL
Interval -22.0 to 18.0
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Intention to treat analysis with LOCF if week 48 fasting HDL data was missing and post-baseline fasting HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).
Outcome measures
| Measure |
NucleomaxX
n=77 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=73 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline)
|
1 mg/dL
Interval -3.0 to 4.0
|
-1 mg/dL
Interval -6.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Intention to treat analysis with LOCF if week 48 fasting non-HDL data was missing and post-baseline fasting non-HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF or due to associated triglyceride was \>400 mg/dL. Subjects were stratified based on ART (d4T or AZT).
Outcome measures
| Measure |
NucleomaxX
n=66 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=61 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline)
|
2 mg/dL
Interval -13.0 to 18.0
|
2 mg/dL
Interval -18.0 to 17.0
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Intention to treat analysis with LOCF if week 48 fasting LDL data was missing and post-baseline fasting LDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).
Outcome measures
| Measure |
NucleomaxX
n=67 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=61 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline)
|
1 mg/dL
Interval -12.0 to 23.0
|
-3 mg/dL
Interval -21.0 to 15.0
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Intention to treat analysis with LOCF if week 48 fasting triglyceride data was missing and post-baseline fasting triglyceride was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).
Outcome measures
| Measure |
NucleomaxX
n=77 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=75 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in Fasting Triglycerides From Baseline (Week 48 - Baseline)
|
-8 mg/dL
Interval -29.0 to 49.0
|
13 mg/dL
Interval -28.0 to 62.0
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Intention to treat analysis with LOCF if week 48 hemoglobin data was missing and post-baseline hemoglobin was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).
Outcome measures
| Measure |
NucleomaxX
n=83 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=81 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in Hemoglobin From Baseline (Week 48 - Baseline)
|
0.3 g/dL
Interval -0.5 to 0.8
|
0 g/dL
Interval -0.8 to 0.6
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Intention to treat analysis with LOCF if week 48 leukocyte data was missing and post-baseline leukocyte was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).
Outcome measures
| Measure |
NucleomaxX
n=83 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=81 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in Leukocytes From Baseline (Week 48 - Baseline)
|
0.2 cells*10^3/L
Interval -0.4 to 1.1
|
0.1 cells*10^3/L
Interval -0.2 to 1.0
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Intention to treat analysis with LOCF if week 48 creatine kinase data was missing and post-baseline creatine kinase was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).
Outcome measures
| Measure |
NucleomaxX
n=79 Participants
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=81 Participants
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Change in Creatine Kinase From Baseline (Week 48 - Baseline)
|
1 IU/L
Interval -39.0 to 45.0
|
5 IU/L
Interval -31.0 to 68.0
|
Adverse Events
NucleomaxX
Serious events: 4 serious events
Other events: 75 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NucleomaxX
n=83 participants at risk
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=82 participants at risk
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
1.2%
1/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
1/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
General disorders
Chest pain
|
1.2%
1/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.2%
1/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
1.2%
1/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
1.2%
1/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
Other adverse events
| Measure |
NucleomaxX
n=83 participants at risk
Participants received NucleomaxX for uridine through week 48
|
Placebo
n=82 participants at risk
Participants received NucleomaxX placebo through week 48
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
11/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
8.5%
7/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Gastrointestinal disorders
Nausea
|
19.3%
16/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
7.3%
6/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Gastrointestinal disorders
Vomiting
|
8.4%
7/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
3.7%
3/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Alanine aminotransferase increased
|
6.0%
5/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
4.9%
4/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood bilirubin increased
|
9.6%
8/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
8.5%
7/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood cholesterol
|
6.0%
5/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
4.9%
4/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood cholesterol abnormal
|
42.2%
35/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
35.4%
29/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood creatine phosphokinase increased
|
20.5%
17/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
25.6%
21/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood glucose abnormal
|
27.7%
23/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
26.8%
22/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood glucose increased
|
7.2%
6/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
3.7%
3/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood lactic acid abnormal
|
14.5%
12/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
12.2%
10/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood phosphorus decreased
|
3.6%
3/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
9.8%
8/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood triglycerides
|
8.4%
7/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
12.2%
10/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Low density lipoprotein abnormal
|
33.7%
28/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
19.5%
16/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Neuropathy peripheral
|
31.3%
26/83 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
41.5%
34/82 • From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
Additional Information
ACTG ClinicalTrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place