Completed
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2014-04-17
460
Participants Needed
15
Research Sites
N/A
Total Duration
The purpose of this study is to see how taking certain anti-HIV drugs affects the way the body metabolizes fat. This study will evaluate patients who are enrolled in CPCRA 058 (the FIRST \[Flexible Initial Retrovirus Suppressive Therapies\] study) by looking for changes in cholesterol levels, levels of fat in the blood, and body fat distribution. Patients in the FIRST study receive an anti-HIV drug regimen which contains a protease inhibitor (PI), a nonnucleoside reverse transcriptase inhibitor (NNRTI), or both. Anti-HIV drug therapy using PIs has become very common treatment for HIV-positive patients. Recently, however, serious side effects involving how the body uses fat are being reported in patients taking PIs. Examples of these side effects are a redistribution of body fat, high cholesterol level, and development of diabetes. However, some of these side effects have also been seen in patients who are not taking PIs. It is important to determine whether or not these side effects are directly related to PI use. In this study, patients on different drug combinations, either with or without a PI, will be compared.
CONDITIONS
The Effect of Anti-HIV Therapy on Fat Metabolism in HIV-Positive Patients
You may qualify if you...
Inclusion Criteria
Patients may be eligible for this study if they:
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Total: 15 locations
1
Community Consortium / UCSF
San Francisco, California, United States, 94110
Status Unknown
2
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 802044507
Status Unknown
3
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, United States, 20422
Status Unknown
4
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 303081962
Status Unknown
5
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
Status Unknown
6
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
Status Unknown
7
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, United States, 48201
Status Unknown
8
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Status Unknown
9
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, United States, 08103
Status Unknown
10
North Jersey Community Research Initiative
Newark, New Jersey, United States, 071032842
Status Unknown
11
Partners in Research / New Mexico
Albuquerque, New Mexico, United States, 87131
Status Unknown
12
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
13
The Research and Education Group
Portland, Oregon, United States, 97210
Status Unknown
14
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Status Unknown
15
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, United States, 232980049
Status Unknown
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Fehmida Visnegarwala, Li Chen, Subha Raghavan...
https://pubmed.ncbi.nlm.nih.gov/15845431Fehmida Visnegarwala, Judith C Shlay, Vaughn Barry...
https://pubmed.ncbi.nlm.nih.gov/17621461