Phase 2
Completed N=36
HIV and Fat Accumulation
Source: ClinicalTrials.gov NCT01088295 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: Median Change in Visceral Adipose Tissue (VAT) Volume — -4.6 cm^2
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Change in Visceral Adipose Tissue (VAT) Volume |
-4.6 | — |
Eligibility Criteria
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) 3 x ULN (upper limit of normal)
Data sourced from ClinicalTrials.gov (NCT01088295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.