Phase 2 N=36 Treatment

HIV and Fat Accumulation

HIV Infection

Bottom Line

View on ClinicalTrials.gov: NCT01088295 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2013

Primary outcome: Primary: Median Change in Visceral Adipose Tissue (VAT) Volume — -4.6 cm^2

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Telmisartan (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Change in Visceral Adipose Tissue (VAT) Volume	-4.6	—

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.

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)

View full record on ClinicalTrials.gov →

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.