A Study of Capravirine Plus VIRACEPT Plus Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Patients Who Failed Previous Anti-HIV Treatments

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to see if the addition of capravirine to VIRACEPT (nelfinavir mesylate) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) is an effective combination drug therapy for HIV patients who have failed a nonnucleoside reverse transcriptase inhibitor (NNRTI) therapy.

Key facts

Study ID

NCT00006211

Run by

Agouron Pharmaceuticals

People needed

350

Starts

2000-02-01

Expected to finish

2001-04-01

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 HIV positive.
• Are at least 18 years old.
• Are currently taking an NNRTI and at least 1 NRTI for at least 28 days and failing that therapy. (Patients who began an NRTI therapy without an NNRTI and then added an NNRTI may also enroll.)
• Are on the current NNRTI plus NRTI therapy at the time of the screening visit.
• Have a CD4 count greater than 50/mm3 and viral load greater than 2,000 copies/ml at the screening visit.
• Have adequate blood, kidney, and liver functions.
• Agree to use a barrier method of birth control while on the study.
• Agree to use additional methods of birth control if less than 2 years postmenopausal.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Are using or have received other investigative drugs within 28 days of receiving the first dose of study drug.
• Are using or have received any medications or radiation treatments that interfere with the study drug within 28 days of receiving the first dose of study drug.
• Have had prior treatment with capravirine or any protease inhibitors.
• Are pregnant or breast-feeding.
• Have an active infection or serious medical condition.
• Have a mental, social, or addictive disorder that may interfere with study treatment.

Where it is running

• Lisa Bauman — San Diego, California, United States

Full record on ClinicalTrials.gov

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