HIV and Fat Accumulation (MATH)
This study has been completed.
Sponsor:
University of California, Los Angeles
Collaborator:
California HIV/AIDS Research Program
Information provided by (Responsible Party):
Jordan E. Lake M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01088295
First received: March 16, 2010
Last updated: February 15, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: Telmisartan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Metabolic Abnormalities, Telmisartan and HIV Infection |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Telmisartan
U.S. FDA Resources
Further study details as provided by University of California, Los Angeles:
Primary Outcome Measures:
- Median Change in Visceral Adipose Tissue (VAT) Volume [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography
Secondary Outcome Measures:
- Safety and Tolerability of Telmisartan [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 35 |
| Study Start Date: | May 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Telmisartan
Telmisartan 40mg po daily for 24 weeks
|
Drug: Telmisartan
Other Name: Micardis
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 <750 cells/mm3 Hemoglobin <10 gm/dL ClCr < 30 ml/min (estimated by Cockcroft-Gault equation) AST or ALT > 3 x ULN
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088295
Locations
| United States, California | |
| UCLA CARE Center | |
| Los Angeles, California, United States, 90035 | |
Sponsors and Collaborators
University of California, Los Angeles
California HIV/AIDS Research Program
Investigators
| Principal Investigator: | Jordan Lake, M.D. | UCLA CARE Center |
More Information
No publications provided by University of California, Los Angeles
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jordan E. Lake M.D., Fellow, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01088295 History of Changes |
| Other Study ID Numbers: | MATH |
| Study First Received: | March 16, 2010 |
| Results First Received: | January 16, 2013 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, Los Angeles:
|
Metabolic HIV Fat accumulation |
AIDS Metabolic abnormalities in HIV infection HIV Infections |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Telmisartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013