Trial Outcomes & Findings for Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (NCT NCT00119405)
NCT ID: NCT00119405
Last Updated: 2017-03-30
Results Overview
Mitochondrial gene expression: mtDNA levels are used to quantify this outcome measure.
Recruitment status
COMPLETED
Target enrollment
18 participants
Primary outcome timeframe
96 weeks
Results posted on
2017-03-30
Participant Flow
Recruitment occurred from 6/2005 to 11/2008. Participants were recruited from 3 HIV clinics in Cleveland, with the majority from the clinic at University Hospitals Case Medical Center.
Participants had to be HIV+ and naive to ARVs.
Participant milestones
| Measure |
ARV Naive
ARV naive
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
ARV Naive
ARV naive
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Baseline characteristics by cohort
| Measure |
ARV Naive
n=18 Participants
ARV naive
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
33.88 years
STANDARD_DEVIATION 8.48 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 96 weeksMitochondrial gene expression: mtDNA levels are used to quantify this outcome measure.
Outcome measures
| Measure |
ARV Naive
n=18 Participants
ARV naive (have never been on antiretrovirals before)
|
|---|---|
|
Mitochondrial Function (mtDNA Levels)
|
1372 copies per cell
Interval 532.0 to 2721.0
|
Adverse Events
ARV Naive
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARV Naive
n=18 participants at risk
ARV naive (have never been on antiretrovirals before)
|
|---|---|
|
Endocrine disorders
Pancreatitis (Grade 3)
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Right Lower Lobe (RLL) Pneumonia (Grade 3)
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia (Grade 2)
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
ARV Naive
n=18 participants at risk
ARV naive (have never been on antiretrovirals before)
|
|---|---|
|
Skin and subcutaneous tissue disorders
Incisional Seroma
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Incisional Hematoma (Grade 1)
|
11.1%
2/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Infected Incisional Hematoma (Grade 2)
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Low glucose 34 (Grade 3)
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Low glucose 48 (Grade 2)
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Tachycardia (Grade 2)
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone Mineral Density (BMD)/T scores -2.3 and -3.2
|
5.6%
1/18 • Number of events 1
|
|
Hepatobiliary disorders
Elevated Aspartate aminotransferase (AST) (Grades 2 and 3)
|
16.7%
3/18 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Elevated creatine kinase (CK) levels (Grades 3 and 4)
|
16.7%
3/18 • Number of events 3
|
|
Hepatobiliary disorders
Elevated alanine aminotransferase (ALT) 207 (Grade 2)
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Elevated Cholesterol 257 (Grade 2)
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Elevated low-density lipoprotein (LDL) 175 (Grade 2)
|
5.6%
1/18 • Number of events 1
|
|
Blood and lymphatic system disorders
Low absolute neutrophil count (ANC) (Grades 2 and 3)
|
11.1%
2/18 • Number of events 3
|
|
Blood and lymphatic system disorders
Low white blood cell (WBC) count (Grade 2)
|
5.6%
1/18 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place