HIV Infections Clinical Trial
Official title:
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
NCT number | NCT00004999 |
Other study ID # | 286C |
Secondary ID | AG1549-504 |
Status | Suspended |
Phase | Phase 2 |
First received | March 21, 2000 |
Last updated | June 23, 2005 |
Start date | August 1999 |
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.
Status | Suspended |
Enrollment | 350 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria 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. Exclusion Criteria 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. |
Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | QEII Health Science Centre | Halifax | Nova Scotia |
Canada | Montreal Chest Institute | Montreal | Quebec |
Canada | Sunnybrook Health Science Centre | Toronto | Ontario |
Canada | Canadian HIV Trials Network | Vancouver | British Columbia |
Dominican Republic | Immunity Care and Research Inc | Santo Domingo | |
Puerto Rico | Univ of Puerto Rico School of Med | Rio Piedras | |
Puerto Rico | Clinical Research Puerto Rico Inc | San Juan | |
United States | IDC Research Initiative | Altamonte Springs | Florida |
United States | Sky Blue | Boise | Idaho |
United States | Fenway Community Health Ctr | Boston | Massachusetts |
United States | Bach and Godofsky | Bradenton | Florida |
United States | Med Univ of South Carolina | Charleston | South Carolina |
United States | Paul Alessi | Cherry Hill | New Jersey |
United States | Northwestern Univ Med Ctr | Chicago | Illinois |
United States | The CORE Ctr | Chicago | Illinois |
United States | Univ of Cincinnati / Holmes Hosp | Cincinnati | Ohio |
United States | Southwest Infectious Diseases Associates | Dallas | Texas |
United States | VAMC New Jersey Healthcare System | East Orange | New Jersey |
United States | Community Health Care | Fort Lauderdale | Florida |
United States | Univ TX Galveston Med Branch | Galveston | Texas |
United States | Hampton Roads Med Specialists | Hampton | Virginia |
United States | St Mary's Hosp Family Treatment Ctr | Hoboken | New Jersey |
United States | Joseph C Gathe | Houston | Texas |
United States | Thomas Street Clinic | Houston | Texas |
United States | Indiana Univ Infectious Disease Research Clinic | Indianapolis | Indiana |
United States | Univ of Iowa | Iowa City | Iowa |
United States | Univ of Florida | Jacksonville | Florida |
United States | Kansas City AIDS Research Consortium | Kansas City | Missouri |
United States | Univ of Southern California | Los Angeles | California |
United States | University of Louisville / ID Division | Louisville | Kentucky |
United States | South Shore Hosp | Miami | Florida |
United States | Specialty Med Care Ctrs of South Florida Inc | Miami | Florida |
United States | Univ of Miami School of Medicine | Miami | Florida |
United States | Wisconsin AIDS Research Consortium | Milwaukee | Wisconsin |
United States | Hawthorne Med Associates / PAACA | New Bedford | Massachusetts |
United States | HIV Outpatient Clinics / LA State Univ Med Ctr | New Orleans | Louisiana |
United States | Bentley-Salick Medical Practice PC | New York | New York |
United States | Univ of Med & Dentistry of New Jersey | Newark | New Jersey |
United States | Highland Gen Hosp / San Francisco Gen Hosp | Oakland | California |
United States | Univ of Nebraska Medical Ctr | Omaha | Nebraska |
United States | Orange County Health Dept | Orlando | Florida |
United States | Larry Bush | Palm Springs | Florida |
United States | ViRx Inc | Palm Springs | California |
United States | Univ of Rochester Med Ctr | Rochester | New York |
United States | Research & Treatment at the California Pacific Med Ctr | San Francisco | California |
United States | Infectious Diseases Associates | Sarasota | Florida |
United States | Infectious Disease Research Institute | Tampa | Florida |
United States | Harbor - UCLA Med Ctr | Torrance | California |
United States | Arizona Clinical Research Ctr Inc | Tucson | Arizona |
United States | Treasure Coast Infectious Disease Consultants | Vero Beach | Florida |
United States | Julio Arroyo | West Columbia | South Carolina |
United States | Univ of Kansas School of Medicine | Wichita | Kansas |
United States | Polk County Health Dept | Winter Haven | Florida |
Lead Sponsor | Collaborator |
---|---|
Agouron Pharmaceuticals |
United States, Canada, Dominican Republic, Puerto Rico,
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