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

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

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 weeks

Population: as-treated analysis

VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography

Outcome measures

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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place