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

April 16, 2014 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment

460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Community Consortium / UCSF
    • Colorado
      • Denver, Colorado, United States, 802044507
        • Denver CPCRA / Denver Public Hlth
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Washington Reg AIDS Prog / Dept of Infect Dis
    • Georgia
      • Atlanta, Georgia, United States, 303081962
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60657
        • AIDS Research Alliance - Chicago
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp
      • Detroit, Michigan, United States, 48201
        • Wayne State Univ - WSU/DMC / Univ Hlth Ctr
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Southern New Jersey AIDS Cln Trials / Dept of Med
      • Newark, New Jersey, United States, 071032842
        • North Jersey Community Research Initiative
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Partners in Research / New Mexico
    • New York
      • New York, New York, United States, 10037
        • Harlem AIDS Treatment Grp / Harlem Hosp Ctr
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Research and Education Group
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
    • Virginia
      • Richmond, Virginia, United States, 232980049
        • Richmond AIDS Consortium / Div of Infect Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Subha Raghavan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

April 17, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPCRA 061
  • 11616 (Registry Identifier: DAIDS-ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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