Safety and Effectiveness of a New Anti-HIV Drug (AG1549) in Combination With Other Anti-HIV Drugs in HIV-Infected Patients
A Phase II, Open-Label Study of AG1549 in Combination With Other Antiretroviral Agents in Treatment-Naive HIV-Infected Patients
2 other identifiers
interventional
30
2 countries
10
Brief Summary
The purpose of this study is to see if two different doses of AG1549 plus other anti-HIV drugs are safe and effective in 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 below P25 for phase_2 hiv-infections
10 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
November 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 (10)
Clin Research of West Florida
Clearwater, Florida, 33765, United States
Community Health Care
Fort Lauderdale, Florida, 33306, United States
South Shore Hosp
Miami, Florida, 33139, United States
Infectious Diseases Associates
Sarasota, Florida, 34239, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Catholic Med Ctr
Jamaica, New York, 11432, United States
Liberty Medical
New York, New York, 10014, United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15221, United States
Immunity Care and Research Inc
Santo Domingo, Dominican Republic