Combination Treatment Using Capravirine (AG1549), Nelfinavir, and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy
A Phase II, Single-Blind, Randomized, Placebo-Controlled Study of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Subjects Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen
2 other identifiers
interventional
75
2 countries
34
Brief Summary
The purpose of this study is to look at the effectiveness of an anti-HIV drug combination that adds capravirine in patients who have failed their first drug combination treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
March 15, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 2001
March 15, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this trial if they:
- Are HIV-positive.
- Have a CD4 cell count more than 50/mm3.
- Are at least 18 years old.
- Have adequate blood, kidney, and liver functions.
- Are currently taking an anti-HIV drug combination of an NNRTI plus 1 or more NRTIs for more than 28 days and are failing that combination.
You may not qualify if:
- Patients will not be eligible for this trial if they:
- Have had any protease inhibitor or capravirine treatment.
- Have been given any drug that interferes with their immune system or with the study drugs within 28 days of study entry.
- Have had radiation therapy within 28 days of study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Phoenix Body Positive
Phoenix, Arizona, 85016, United States
Pacific Oaks Med Group
Beverly Hills, California, 90211, United States
First Choice Medical
Palm Springs, California, 92262, United States
Apogee Med Group
San Diego, California, 92101, United States
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, 94109, United States
Kaiser Foundation Hospital
San Francisco, California, 94118, United States
Harbor - UCLA Med Ctr
Torrance, California, 90502, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Bach and Godofsky
Bradenton, Florida, 34205, United States
Clin Research of West Florida
Clearwater, Florida, 33765, United States
Community Health Care
Fort Lauderdale, Florida, 33306, United States
Therafirst Med Ctr
Fort Lauderdale, Florida, 33308, United States
South Shore Hosp
Miami, Florida, 33139, United States
Immunity Care and Research Inc
Miami Beach, Florida, 33139, United States
Orange County Health Dept
Orlando, Florida, 32805, United States
Infectious Diseases Associates
Sarasota, Florida, 34239, United States
Hillsborough County Health Dept
Tampa, Florida, 33602, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960, United States
Polk County Health Dept
Winter Haven, Florida, 33881, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Braude Mermin Spivey MD PC
Atlanta, Georgia, 30309, United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114, United States
Fenway Community Health Ctr
Boston, Massachusetts, 02115, United States
VAMC New Jersey Healthcare System
East Orange, New Jersey, 07018, United States
Jersey Shore Med Ctr
Neptune City, New Jersey, 07753, United States
Infectious Disease Assoc of Central Jersey
Somerville, New Jersey, 08876, United States
Biomedical Research Alliance of New York
Jamaica, New York, 11432, United States
North Shore Univ Hosp
Manhasset, New York, 11030, United States
Liberty Medical
New York, New York, 10014, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77555, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
Clinical Research Puerto Rico Inc
San Juan, 009091711, Puerto Rico