Trial record 7 of 27 for:
" March 03, 2010":" April 02, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
HIV and Fat Accumulation (MATH)
This study has been completed.
California HIV/AIDS Research Program
Information provided by (Responsible Party):
Jordan E. Lake M.D., University of California, Los Angeles
First received: March 16, 2010
Last updated: June 19, 2014
Last verified: June 2014
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Metabolic Abnormalities, Telmisartan and HIV Infection
Primary Outcome Measures:
Secondary Outcome Measures:
- Safety and Tolerability of Telmisartan [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2011 (Final data collection date for primary outcome measure)
Telmisartan 40mg po daily for 24 weeks
Other Name: Micardis
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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)
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088295
|UCLA CARE Center
|Los Angeles, California, United States, 90035 |
University of California, Los Angeles
California HIV/AIDS Research Program
||Jordan Lake, M.D.
||UCLA CARE Center
No publications provided by University of California, Los Angeles
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Jordan E. Lake M.D., Assistant Professor, University of California, Los Angeles
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 16, 2010
|Results First Received:
||January 16, 2013
||June 19, 2014
||United States: Food and Drug Administration
Keywords provided by University of California, Los Angeles:
Metabolic abnormalities in HIV infection
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action