The Effect of Anti-HIV Therapy on Fat Metabolism in HIV-Positive Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00001102 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: April 17, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease |
---|
HIV Infections |
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 participants |
Official Title: | Metabolic Consequences of Highly Active Antiretroviral Therapy (HAART) in HIV-Positive Individuals |
Actual Study Completion Date : | June 2006 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001102
United States, California | |
Community Consortium / UCSF | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
Denver CPCRA / Denver Public Hlth | |
Denver, Colorado, United States, 802044507 | |
United States, District of Columbia | |
Washington Reg AIDS Prog / Dept of Infect Dis | |
Washington, District of Columbia, United States, 20422 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 303081962 | |
United States, Illinois | |
AIDS Research Alliance - Chicago | |
Chicago, Illinois, United States, 60657 | |
United States, Louisiana | |
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
New Orleans, Louisiana, United States, 70112 | |
United States, Michigan | |
Wayne State Univ - WSU/DMC / Univ Hlth Ctr | |
Detroit, Michigan, United States, 48201 | |
Henry Ford Hosp | |
Detroit, Michigan, United States, 48202 | |
United States, New Jersey | |
Southern New Jersey AIDS Cln Trials / Dept of Med | |
Camden, New Jersey, United States, 08103 | |
North Jersey Community Research Initiative | |
Newark, New Jersey, United States, 071032842 | |
United States, New Mexico | |
Partners in Research / New Mexico | |
Albuquerque, New Mexico, United States, 87131 | |
United States, New York | |
Harlem AIDS Treatment Grp / Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
United States, Oregon | |
The Research and Education Group | |
Portland, Oregon, United States, 97210 | |
United States, Pennsylvania | |
Philadelphia FIGHT | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Virginia | |
Richmond AIDS Consortium / Div of Infect Diseases | |
Richmond, Virginia, United States, 232980049 |
Study Chair: | Subha Raghavan |
Publications of Results:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001102 History of Changes |
Other Study ID Numbers: |
CPCRA 061 11616 ( Registry Identifier: DAIDS-ES ) |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | April 17, 2014 |
Last Verified: | April 2014 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination HIV Protease Inhibitors Reverse Transcriptase Inhibitors Body Composition |
Anti-HIV Agents Cholesterol Triglycerides |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |