NCT00001102

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

First QC Date

November 2, 1999

Last Update Submit

April 16, 2014

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationHIV Protease InhibitorsReverse Transcriptase InhibitorsBody CompositionAnti-HIV AgentsCholesterolTriglycerides

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Community Consortium / UCSF

San Francisco, California, 94110, United States

Location

Denver CPCRA / Denver Public Hlth

Denver, Colorado, 802044507, United States

Location

Washington Reg AIDS Prog / Dept of Infect Dis

Washington D.C., District of Columbia, 20422, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 303081962, United States

Location

AIDS Research Alliance - Chicago

Chicago, Illinois, 60657, United States

Location

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, 70112, United States

Location

Wayne State Univ - WSU/DMC / Univ Hlth Ctr

Detroit, Michigan, 48201, United States

Location

Henry Ford Hosp

Detroit, Michigan, 48202, United States

Location

Southern New Jersey AIDS Cln Trials / Dept of Med

Camden, New Jersey, 08103, United States

Location

North Jersey Community Research Initiative

Newark, New Jersey, 071032842, United States

Location

Partners in Research / New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Harlem AIDS Treatment Grp / Harlem Hosp Ctr

New York, New York, 10037, United States

Location

The Research and Education Group

Portland, Oregon, 97210, United States

Location

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

Richmond AIDS Consortium / Div of Infect Diseases

Richmond, Virginia, 232980049, United States

Location

Related 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):331-7. doi: 10.1016/j.jinf.2004.06.001.

    PMID: 15845431RESULT

  • 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/ethnic origins. HIV Clin Trials. 2007 May-Jun;8(3):145-54. doi: 10.1310/hct0803-145.

    PMID: 17621461RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Subha Raghavan

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

June 1, 2006

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

US(15)