Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

Completed · Not applicable

Conditions studied: HIV Infections

In brief

This study will compare an anti-HIV drug combination of protease inhibitor plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) to one that includes three nucleoside reverse transcriptase inhibitors (NRTIs) plus an NNRTI. NNRTIs, NRTIs, and protease inhibitors are all types of anti-HIV drugs that block the virus in some way. This study will try to find out if a treatment regimen containing a protease inhibitor plus an NNRTI has a different effect on the rise of CD4 cells compared to a treatment made up of three NRTIs plus an NNRTI. CD4 cells are cells of the immune system that fight infection. This study will also try to see if the combination of drugs used in this study is safe to use in HIV-positive patients.

Key facts

Study ID

NCT00004855

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

55

Expected to finish

2005-04-01

Last updated by the study team

2021-11-01

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 18 years of age or older.
• Are HIV-positive.
• Have a CD4 count of 500 cells/mm3 or less.
• Have a viral load greater than 5,000 and less than 100,000 copies/ml.
• Are willing to use barrier methods of birth control (such as condoms) during the study and for 12 weeks after stopping treatment.
• Will most likely respond well to nevirapine. This is determined by the results of a test.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have ever taken any anti-HIV drugs. (Seven days or less of treatment will be allowed if it was received more than 30 days before study entry.)
• Have pancreatitis (an inflamed pancreas) or hepatitis within 2 weeks of study entry.
• Are pregnant or breast-feeding.
• Actively abuse drugs or alcohol which their doctor feels would interfere with the ability to fulfill study requirements.
• Have taken any medications within 14 days of study entry that would interfere with the study drugs.
• Are receiving or need to receive chemotherapy.

Where it is running

• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• Denver Dept of Health and Hosps — Denver, Colorado, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Division of Inf Diseases/ Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• Beth Israel Med Ctr — New York, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Univ of Cincinnati — Cincinnati, Ohio, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States
• MetroHealth Med Ctr — Cleveland, Ohio, United States
• Miriam Hosp / Brown Univ — Providence, Rhode Island, United States
• Univ of Texas Galveston — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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