Status:
COMPLETED
Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Brief Summary
The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV-infected people who have never received anti-HIV therapy be treated with a triple drug regimen (commonly called com...
Detailed Description
A5260s is the optional, metabolic substudy of a phase III, prospective, randomized clinical trial (A5257). For complete details about the parent study A5257, please see ClinicalTrials.gov identifier N...
Eligibility Criteria
Inclusion
- Enrollment in A5257 and intent to enroll in A5001 (ALLRT)
- Signed informed consent
- For A5257 inclusion criteria, please see ClinicalTrials.gov identifier NCT00811954
Exclusion
- Diabetes mellitus, (fasting plasma glucose ≥ 126 mg/dL on two occasions or on hypoglycemic medications).
- Known cardiovascular disease (history of myocardial infarction \[MI\], coronary artery bypass graft surgery, percutaneous coronary intervention, stroke, transient ischemic attack, or peripheral arterial disease with ankle-brachial index of less than 0.9 or claudication)
- Uncontrolled hypothyroidism or hyperthyroidism which in the opinion of the site investigator would affect substudy participation
- Current use of statins, fish oil (greater than 2 grams per day), fibric acid derivatives, or niacin (more than 1000 mg per day) (NOTE: Current use of fish oil and niacin is defined as receiving treatment in the 8 weeks prior to study entry)
- Intention to start pharmacological or surgical intervention for weight loss
- Use of any ART in the 30 days before study entry
- For A5257 exclusion criteria, please see ClinicalTrials.gov identifier NCT00811954
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT00851799
Start Date
June 1 2009
End Date
June 1 2013
Last Update
January 13 2016
Active Locations (26)
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1
USC CRS
Los Angeles, California, United States, 90033
2
UCLA CARE Center CRS
Los Angeles, California, United States, 90035
3
Ucsf Aids Crs
San Francisco, California, United States, 94110
4
Harbor - UCLA Med. Ctr. CRS
Torrance, California, United States, 90502