Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients
A Randomized, Double-Blind, Placebo-Controlled Study of AG1549 in Combination With Viracept (Nelfinavir Mesylate) and Combivir (Zidovudine + Lamivudine) in Treatment-Naive HIV-Infected Patients
2 other identifiers
interventional
350
4 countries
53
Brief Summary
The purpose of this study is to look at the effectiveness of giving a new anti-HIV drug (AG1549) plus Viracept (nelfinavir) plus Combivir (a tablet containing zidovudine plus lamivudine) to HIV-infected patients who are not taking anti-HIV drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
53 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
August 1, 1999
CompletedFirst Submitted
Initial submission to the registry
March 21, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 2001
March 21, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible if they:
- Are HIV-positive.
- Are at least 18 years old.
- Have a CD4 cell count of more than 50 cells/mm3.
- Have an HIV level of more than 5000 copies/ml.
You may not qualify if:
- Patients will not be eligible if they:
- Have ever taken any of the following anti-HIV drugs: nonnucleoside reverse transcriptase inhibitors (NNRTIs), AG1549, Viracept, zidovudine, lamivudine, or Combivir. Other anti-HIV drugs are allowed only if taken for no more than 30 days with the last dose taken more than 6 months prior to study entry.
- Have taken an experimental drug within 28 days of study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712, United States
Univ of Southern California
Los Angeles, California, 90033, United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018, United States
ViRx Inc
Palm Springs, California, 92262, United States
Research & Treatment at the California Pacific Med Ctr
San Francisco, California, 94114, United States
Harbor - UCLA Med Ctr
Torrance, California, 90502, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Bach and Godofsky
Bradenton, Florida, 34205, United States
Community Health Care
Fort Lauderdale, Florida, 33306, United States
Univ of Florida
Jacksonville, Florida, 32209, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
South Shore Hosp
Miami, Florida, 33139, United States
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142, United States
Orange County Health Dept
Orlando, Florida, 32805, United States
Larry Bush
Palm Springs, Florida, 33461, United States
Infectious Diseases Associates
Sarasota, Florida, 34239, United States
Infectious Disease Research Institute
Tampa, Florida, 33614, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960, United States
Polk County Health Dept
Winter Haven, Florida, 33881, United States
Sky Blue
Boise, Idaho, 83704, United States
Northwestern Univ Med Ctr
Chicago, Illinois, 60611, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Univ of Iowa
Iowa City, Iowa, 52242, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214, United States
University of Louisville / ID Division
Louisville, Kentucky, 40202, United States
HIV Outpatient Clinics / LA State Univ Med Ctr
New Orleans, Louisiana, 70112, United States
Fenway Community Health Ctr
Boston, Massachusetts, 02115, United States
Hawthorne Med Associates / PAACA
New Bedford, Massachusetts, 02745, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64111, United States
Univ of Nebraska Medical Ctr
Omaha, Nebraska, 681985400, United States
Paul Alessi
Cherry Hill, New Jersey, 08034, United States
VAMC New Jersey Healthcare System
East Orange, New Jersey, 07018, United States
St Mary's Hosp Family Treatment Ctr
Hoboken, New Jersey, 07030, United States
Univ of Med & Dentistry of New Jersey
Newark, New Jersey, 07103, United States
Bentley-Salick Medical Practice PC
New York, New York, 10003, United States
Univ of Rochester Med Ctr
Rochester, New York, 14642, United States
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, 452670405, United States
Med Univ of South Carolina
Charleston, South Carolina, 29425, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Southwest Infectious Diseases Associates
Dallas, Texas, 75246, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77555, United States
Joseph C Gathe
Houston, Texas, 77004, United States
Thomas Street Clinic
Houston, Texas, 77009, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
Wisconsin AIDS Research Consortium
Milwaukee, Wisconsin, 53203, United States
Canadian HIV Trials Network
Vancouver, British Columbia, Canada
QEII Health Science Centre
Halifax, Nova Scotia, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Montreal Chest Institute
Montreal, Quebec, Canada
Immunity Care and Research Inc
Santo Domingo, Dominican Republic
Univ of Puerto Rico School of Med
Rio Piedras, 00935, Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, 009091711, Puerto Rico