HIV Infection
Conditions
Keywords
Metabolic, HIV, Fat accumulation, AIDS, Metabolic abnormalities in HIV infection, HIV Infections
Brief summary
This is a research study to see whether fat accumulation either under the skin or in the body's organs, for example, the liver, improves in men and women who take a drug called telmisartan. The investigators will be looking at how the amount of fat in the body changes when HIV-positive persons on effective anti-HIV therapy take telmisartan. The investigators will be using a CT scan to make this comparison. Telmisartan is not an HIV medication. It is a medication used to treat blood pressure, but has been shown to decrease fat in the organs in people both with and without high blood pressure. The study involves 8 visits over a period of about 24 weeks.
Interventions
DRUGTelmisartan
Sponsors
California HIV/AIDS Research Program
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV positive men and women 18 years and older * HIV-1 infection as documented by ELISA and confirmed by Western blot or plasma HIV-1 RNA \>2000 on two occasions * Documented central fat accumulation * HIV RNA documented to be less than 50 copies/mL at screening and undetectable by assay of choice for at least 12 weeks prior to entry * Current antiretroviral therapy with a suppressive, highly active antiretroviral regimen. * Systolic BP \>115mmHg. * Ability and willingness to provide informed consent
Exclusion criteria
* Pregnancy (current or within the last 6 months) or nursing * Uncontrolled hypertension * Prohibited concomitant medications * Subjects with untreated hyperlipidemia must be willing to abstain from initiating therapy for the 24 week duration fo the study. * Subjects undergoing treatment for diabetes with oral hypoglycemic agents must be willing to remain on their current dose of insulin sensitizing agents for the duration of the study. * Known, untreated renal artery stenosis * Unstable coronary artery disease/angina or decompensated congestive heart failure. * Any history of intolerance to any member of the angiotensin receptor blocker class of agents. * Need for ongoing potassium supplementation. * Screening laboratory values as follows ANC (absolute neutrophil count) \<750 cells/mm3 Hemoglobin \<10 gm/dL ClCr (creatinine clearance)\< 30 ml/min (estimated by Cockcroft-Gault equation) AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \> 3 x ULN (upper limit of normal)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Change in Visceral Adipose Tissue (VAT) Volume | Baseline and 24 weeks | VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited between May and October 2010 at the UCLA CARE Center.
Participants by arm
| Arm | Count |
|---|---|
| Telmisartan Telmisartan 40mg po daily for 24 weeks | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Telmisartan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 7.4 |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Median Change in Visceral Adipose Tissue (VAT) Volume
VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography
Time frame: Baseline and 24 weeks
Population: as-treated analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telmisartan | Median Change in Visceral Adipose Tissue (VAT) Volume | -4.6 cm^2 |