Trial Outcomes & Findings for Dipeptidyl Peptidase-4 Inhibition and Immune Function in HIV (NCT NCT01093651)
NCT ID: NCT01093651
Last Updated: 2014-02-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
20 participants
Primary outcome timeframe
Monthly for 4 months
Results posted on
2014-02-17
Participant Flow
HIV-infected adults (18 - 65 years old) were recruited from the AIDS Clinical Trials Unit and the Infectious Diseases Clinic at Washington University School of Medicine. Thirty-one candidates were screened and 20 were enrolled; all participants were HIV positive but were otherwise healthy with stable immunologic and virologic status on HAART.
Twenty participants were randomized to n=10 placebo or n=10 sitagliptin (Januvia(R)). Eleven volunteers were screened and found ineligible (see eligibility criteria), or did not choose to participate in the study.
Participant milestones
| Measure |
Placebo
Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Placebo : Daily placebo for 4 months
|
DPPIV Inhibition
Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dipeptidyl Peptidase-4 Inhibition and Immune Function in HIV
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Placebo : Daily placebo for 4 months
|
DPPIV Inhibition
n=10 Participants
Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 15 • n=99 Participants
|
36 years
STANDARD_DEVIATION 9 • n=107 Participants
|
38 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Monthly for 4 monthsPopulation: CD4+ T-cell count
Outcome measures
| Measure |
DPPIV Inhibition
n=10 Participants
Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months
|
Placebo
n=10 Participants
Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Placebo : Daily placebo for 4 months
|
|---|---|---|
|
CD4+ T-cell Count
Baseline
|
648 cells/µL
Standard Deviation 185
|
602 cells/µL
Standard Deviation 91
|
|
CD4+ T-cell Count
Week 4
|
750 cells/µL
Standard Deviation 225
|
689 cells/µL
Standard Deviation 153
|
|
CD4+ T-cell Count
Week 8
|
656 cells/µL
Standard Deviation 207
|
696 cells/µL
Standard Deviation 194
|
|
CD4+ T-cell Count
Week 12
|
706 cells/µL
Standard Deviation 168
|
686 cells/µL
Standard Deviation 167
|
|
CD4+ T-cell Count
Week 16
|
636 cells/µL
Standard Deviation 173
|
681 cells/µL
Standard Deviation 151
|
PRIMARY outcome
Timeframe: Monthly for 6 monthsPercentage of participants with plasma HIV RNA copy number less than 48 copies/mL
Outcome measures
| Measure |
DPPIV Inhibition
n=10 Participants
Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months
|
Placebo
n=10 Participants
Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Placebo : Daily placebo for 4 months
|
|---|---|---|
|
Plasma HIV Viremia (Viral Load)
Baseline
|
100 percentage of participants below 48 c/mL
|
100 percentage of participants below 48 c/mL
|
|
Plasma HIV Viremia (Viral Load)
Week 4
|
100 percentage of participants below 48 c/mL
|
100 percentage of participants below 48 c/mL
|
|
Plasma HIV Viremia (Viral Load)
Week 8
|
100 percentage of participants below 48 c/mL
|
100 percentage of participants below 48 c/mL
|
|
Plasma HIV Viremia (Viral Load)
Week 12
|
100 percentage of participants below 48 c/mL
|
100 percentage of participants below 48 c/mL
|
|
Plasma HIV Viremia (Viral Load)
Week 16
|
100 percentage of participants below 48 c/mL
|
100 percentage of participants below 48 c/mL
|
|
Plasma HIV Viremia (Viral Load)
Week 24
|
100 percentage of participants below 48 c/mL
|
100 percentage of participants below 48 c/mL
|
SECONDARY outcome
Timeframe: Baseline, week 8, week 16Population: sTNFR2
serum soluble tumor necrosis factor receptor-2 concentration
Outcome measures
| Measure |
DPPIV Inhibition
n=10 Participants
Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months
|
Placebo
n=10 Participants
Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Placebo : Daily placebo for 4 months
|
|---|---|---|
|
Soluble TNFR2; Serum Biomarkers of Immune Activation
Baseline
|
2436 pg/mL
Standard Deviation 431
|
2220 pg/mL
Standard Deviation 389
|
|
Soluble TNFR2; Serum Biomarkers of Immune Activation
week 8
|
2617 pg/mL
Standard Deviation 638
|
2218 pg/mL
Standard Deviation 411
|
|
Soluble TNFR2; Serum Biomarkers of Immune Activation
week 16
|
2388 pg/mL
Standard Deviation 449
|
2279 pg/mL
Standard Deviation 415
|
SECONDARY outcome
Timeframe: Baseline, week 8, week 16Population: SDF1α
serum stromal cell-derived factor-1α concentration
Outcome measures
| Measure |
DPPIV Inhibition
n=10 Participants
Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months
|
Placebo
n=10 Participants
Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Placebo : Daily placebo for 4 months
|
|---|---|---|
|
SDF1α; Serum Biomarkers of Immune Activation
Baseline
|
2378 pg/mL
Standard Deviation 441
|
2327 pg/mL
Standard Deviation 304
|
|
SDF1α; Serum Biomarkers of Immune Activation
week 8
|
1208 pg/mL
Standard Deviation 605
|
2313 pg/mL
Standard Deviation 364
|
|
SDF1α; Serum Biomarkers of Immune Activation
week 16
|
1277 pg/mL
Standard Deviation 490
|
2309 pg/mL
Standard Deviation 400
|
SECONDARY outcome
Timeframe: Baseline, week 8, week 16Population: RANTES
serum Regulated on Activation, Normal T cell Expressed and Secreted concentration
Outcome measures
| Measure |
DPPIV Inhibition
n=10 Participants
Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months
|
Placebo
n=10 Participants
Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Placebo : Daily placebo for 4 months
|
|---|---|---|
|
RANTES; Serum Biomarkers of Immune Activation
Baseline
|
64.4 ng/mL
Standard Deviation 37.2
|
80.8 ng/mL
Standard Deviation 23.2
|
|
RANTES; Serum Biomarkers of Immune Activation
week 8
|
68.5 ng/mL
Standard Deviation 43.0
|
85.3 ng/mL
Standard Deviation 27.7
|
|
RANTES; Serum Biomarkers of Immune Activation
week 16
|
62.8 ng/mL
Standard Deviation 32.3
|
74.9 ng/mL
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: Baseline, week 8, week 16Area under the 75-gr oral glucose tolerance curve (AUCg) based on plasma glucose values measured at 0, 30, 60, 90, and 120 mins post-glucose challenge.
Outcome measures
| Measure |
DPPIV Inhibition
n=10 Participants
Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months
|
Placebo
n=10 Participants
Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Placebo : Daily placebo for 4 months
|
|---|---|---|
|
Oral Glucose Tolerance
Baseline AUCg
|
145.6 mg*min/mL
Standard Deviation 32.5
|
142.5 mg*min/mL
Standard Deviation 26.6
|
|
Oral Glucose Tolerance
Week 8 AUCg
|
133.6 mg*min/mL
Standard Deviation 24.6
|
158.0 mg*min/mL
Standard Deviation 26.7
|
|
Oral Glucose Tolerance
Week 16 AUCg
|
142.5 mg*min/mL
Standard Deviation 21.5
|
157.5 mg*min/mL
Standard Deviation 23.2
|
SECONDARY outcome
Timeframe: Monthly for 4 monthsPopulation: Cumulative frequency over 16 weeks of any self-reported symptoms on the DAIDS scale
Cumulative number of self-reported symptoms based on the Division of AIDS Grading Scale for the Severity of Adult Adverse Events (0-4 scale where 0 is no new symptoms, 4 is serious adverse event or toxicity)
Outcome measures
| Measure |
DPPIV Inhibition
n=10 Participants
Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months
|
Placebo
n=10 Participants
Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Placebo : Daily placebo for 4 months
|
|---|---|---|
|
Self-reported Symptoms
Headache
|
4 total number of self reported symptoms
|
5 total number of self reported symptoms
|
|
Self-reported Symptoms
Hypoglycemia symptoms
|
3 total number of self reported symptoms
|
1 total number of self reported symptoms
|
|
Self-reported Symptoms
GI symptoms
|
3 total number of self reported symptoms
|
8 total number of self reported symptoms
|
|
Self-reported Symptoms
Upper respiratory symptoms
|
5 total number of self reported symptoms
|
10 total number of self reported symptoms
|
|
Self-reported Symptoms
Generalized fatigue
|
2 total number of self reported symptoms
|
5 total number of self reported symptoms
|
|
Self-reported Symptoms
Other (e.g., rash, muscle pain, mood change)
|
5 total number of self reported symptoms
|
6 total number of self reported symptoms
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
DPPIV Inhibition
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Placebo : Daily placebo for 4 months
|
DPPIV Inhibition
n=10 participants at risk
Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count \>350 cells/µL) and virologic (plasma HIV RNA \<50 copies/mL) status.
Sitagliptin : 100 mg sitagliptin daily for 4 months
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia symptoms
|
10.0%
1/10 • Number of events 1 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
20.0%
2/10 • Number of events 3 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
50.0%
5/10 • Number of events 8 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
20.0%
2/10 • Number of events 3 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory symptoms
|
60.0%
6/10 • Number of events 10 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
30.0%
3/10 • Number of events 5 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
|
General disorders
Generalized fatigue
|
30.0%
3/10 • Number of events 5 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
10.0%
1/10 • Number of events 2 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
|
General disorders
Headache
|
40.0%
4/10 • Number of events 5 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
20.0%
2/10 • Number of events 4 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 2 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
10.0%
1/10 • Number of events 1 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
10.0%
1/10 • Number of events 1 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
10.0%
1/10 • Number of events 1 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
|
Psychiatric disorders
Mood change
|
20.0%
2/10 • Number of events 3 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
20.0%
2/10 • Number of events 3 • 16 weeks
SAE or AE Any self reported symptom that was graded greater than 2 on the DAIDS severity scale during the 16 week period. These were reported as a serious or adverse event or toxicity. Other adverse event: Any self-reported symptom that was graded less than or equal to 2 (DAIDS scale) during the 16 week period;these are not serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place