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

NCT00006211 | Completed Phase 2

• 2 other identifiers: 286EAG1549-508
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

Drug Therapy, Combination; HIV Protease Inhibitors; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load; Nelfinavir

Interventions

Capravirine DRUG

Nelfinavir mesylate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Agouron Pharmaceuticals: lead

Study Sites (1)

Lisa Bauman

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

capravirine; Nelfinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: August 31, 2001
• Study Start: February 1, 2000
• Study Completion: April 1, 2001
• Last Updated: June 24, 2005

Record last verified: 2001-03

Locations

US (1)