The Effect of Anti-HIV Therapy on Fat Metabolism in HIV-Positive Patients

HIV Infections Clinical Trial

Official title:

Metabolic Consequences of Highly Active Antiretroviral Therapy (HAART) in HIV-Positive Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001102
• Other study ID #: CPCRA 061
• Secondary ID: 11616
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: April 16, 2014
• Est. completion date: June 2006

Study information

• Verified date: April 2014
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Description:

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. The skinfold and body circumference measurements will be discontinued after the study has collected a minimum of 2 years of follow-up data on all participants. Statistical evaluations are performed on the data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	Partners in Research / New Mexico	Albuquerque	New Mexico
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Southern New Jersey AIDS Cln Trials / Dept of Med	Camden	New Jersey
United States	AIDS Research Alliance - Chicago	Chicago	Illinois
United States	Denver CPCRA / Denver Public Hlth	Denver	Colorado
United States	Henry Ford Hosp	Detroit	Michigan
United States	Wayne State Univ - WSU/DMC / Univ Hlth Ctr	Detroit	Michigan
United States	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana
United States	Harlem AIDS Treatment Grp / Harlem Hosp Ctr	New York	New York
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	The Research and Education Group	Portland	Oregon
United States	Richmond AIDS Consortium / Div of Infect Diseases	Richmond	Virginia
United States	Community Consortium / UCSF	San Francisco	California
United States	Washington Reg AIDS Prog / Dept of Infect Dis	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Visnegarwala F, Chen L, Raghavan S, Tedaldi E. Prevalence of diabetes mellitus and dyslipidemia among antiretroviral naive patients co-infected with hepatitis C virus (HCV) and HIV-1 compared to patients without co-infection. J Infect. 2005 May;50(4):331- — View Citation

Visnegarwala F, Shlay JC, Barry V, Gibert CL, Xiang Y, Wang J, Kotler D, Raghavan S, El-Sadr WM; for Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). Effects of HIV infection on body composition changes among men of different racial/e — View Citation

External Links

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