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Home > "T" Clinical Trials Conditions > The Effect of Anti-HIV Therapy on Fat Metabolism in HIV-Positive Patients  The Effect of Anti-HIV Therapy on Fat Metabolism in HIV-Positive Patients
The Effect of Anti-HIV Therapy on Fat Metabolism in HIV-Positive Patients
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: Close to 3 years into widespread PI use, several toxicities, including metabolic alterations, are being reported increasingly in conjunction with the use of PI-containing regimens. Some of the manifestations of these metabolic alterations include hyper/dyslipidemia, hyperglycemia, insulin resistance and glucose intolerance, lipodystrophy (in face and extremities), and body fat redistribution (e.g., central obesity and buffalo humps). Despite reports of increasing prevalence of metabolic complications among PI users, the question of whether they result from PI therapy has not been answered. Some of these complications, e.g., a decrease in peripheral fat with an increase in visceral fat and buffalo hump, have been observed in HIV-infected individuals who were not receiving PIs. This study compares 3 different antiretroviral regimens used in the FIRST study (CPCRA 058), 1 of which does not contain a PI, and examines metabolic alterations which occur. This study enrolls patients simultaneously co-enrolling in the FIRST protocol; 120 patients from each of the FIRST study strategy groups. At entry, Months 1 and 4, and then every 4 months, blood is drawn to measure serum glucose, insulin, total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride levels. At entry and Months 4, 8, 12, and then every 12 months, body cell mass, and body fat by bioelectrical impedance analysis (BIA) are assessed. [AS PER AMENDMENT 7/5/01: At Months 4, 8, and 12, then every 4 months through closure of the FIRST protocol] patients are weighed and skinfold measurements and body circumference measurements are done. Statistical evaluations are performed on the data.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are enrolled in the FIRST study (CPCRA 058). - Have written informed consent of parent or guardian if under the age of 18.
Total Enrollment: 460
Location and Contact Information:
Overall Study Official:
SubhaRaghavan, Study Chair,
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 232980049
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 303081962
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York City, New York, 10037
United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Community Consortium / UCSF
San Francisco, California, 94110
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Partners in Research / New Mexico
Albuquerque, New Mexico, 87131
United States
Additional Information:
Study ID Numbers: CPCRA 061;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001102
Other Hiv Infections Studies:
1. Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.
2. Immune restoration by lipoic acid in AIDS
3. A Comparison of Two Anti-HIV Treatment Plans
4. Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
5. A Study of Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients
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The Effect of Anti-HIV Therapy on Fat Metabolism in HIV-Positive Patients
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