Trial Outcomes & Findings for HIV and Fat Accumulation (NCT NCT01088295)
NCT ID: NCT01088295
Last Updated: 2019-02-04
Results Overview
VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2019-02-04
Participant Flow
Subjects were recruited between May and October 2010 at the UCLA CARE Center.
Participant milestones
| Measure |
Telmisartan
Telmisartan 40mg po daily for 24 weeks
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HIV and Fat Accumulation
Baseline characteristics by cohort
| Measure |
Telmisartan
n=36 Participants
Telmisartan 40mg po daily for 24 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: as-treated analysis
VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography
Outcome measures
| Measure |
Telmisartan
n=35 Participants
Telmisartan 40mg po daily for 24 weeks
|
|---|---|
|
Median Change in Visceral Adipose Tissue (VAT) Volume
|
-4.6 cm^2
Interval -29.5 to 31.2
|
Adverse Events
Telmisartan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jordan E. Lake, M.D., M.Sc.
University of California, Los Angeles
Phone: (310)557-1891
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place