A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients

Completed · Phase 4

Conditions studied: HIV Infections

In brief

The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.

Key facts

Study ID

NCT00005106

Run by

Glaxo Wellcome

People needed

230

Starts

1999-09-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are at least 18 years old.
• Are HIV-positive.
• Have a CD4 count greater than 50 cells/mm3.
• Have a viral load greater than 1,000 copies/ml but less than 200,000 copies/ml.
• Have never received anti-HIV medications before. (However, less than 1 week of therapy with lamivudine or a protease inhibitor and less than 4 weeks of therapy with other nucleoside reverse transcriptase inhibitors [NRTIs] is allowed. No therapy with nonnucleoside reverse transcriptase inhibitors [NNRTIs] is allowed.)
• Cannot bear children or agree to use effective methods of birth control during the study. Hormonal methods of birth control (such as birth control pills) are not considered effective for this study.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have an active AIDS-defining opportunistic infection or disease that, in the doctor's opinion, would make them unable to participate.
• Are unable, in the opinion of the doctor, to follow the dosing schedule and follow-up visit schedule.
• Have a substance abuse problem that would interfere with taking the medications correctly or attending the clinic visits.
• Are enrolled in another study.
• Cannot take medications by mouth or absorb drugs.
• Have hepatitis.
• Have a serious medical condition such as diabetes, congestive heart failure, or other heart disease.
• Need chemotherapy or radiation therapy (except for local treatment of Kaposi's sarcoma).
• Are taking certain medications.
• Are pregnant or breast-feeding.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Arizona Clinical Research Ctr Inc — Tucson, Arizona, United States
• Longbeach Memorial Med Ctr — Longbeach, California, United States
• Good Samaritan Hosp — Los Angeles, California, United States
• THE Clinic — Los Angeles, California, United States
• AIDS Healthcare Foundation — Los Angeles, California, United States
• Maxine Liggins — Los Angeles, California, United States
• UCLA Care Ctr — Los Angeles, California, United States
• Highland Gen Hosp / San Francisco Gen Hosp — Oakland, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Children's Diagnostic Treatment Ctr — Fort Lauderdale, Florida, United States
• Community Health Care — Fort Lauderdale, Florida, United States
• Comprehensive Care Center — Fort Lauderdale, Florida, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• South Shore Hosp — Miami, Florida, United States
• Orange County Health Dept — Orlando, Florida, United States
• Immunity Care and Research Inc — Plantation, Florida, United States
• Daniel Seekins — Tampa, Florida, United States
• Infectious Disease Research Institute — Tampa, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Ponce de Leon Ctr — Atlanta, Georgia, United States
• Philip Brachman — Atlanta, Georgia, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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