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Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients
This study has been suspended.
Study NCT00004999   Information provided by NIH AIDS Clinical Trials Information Service
First Received: March 21, 2000   Last Updated: June 23, 2005   History of Changes

March 21, 2000
June 23, 2005
August 1999
 
 
 
Complete list of historical versions of study NCT00004999 on ClinicalTrials.gov Archive Site
 
 
 
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

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.

[Note: As of 2/28/2001, due to toxicity studies and concerns for safety, sites were notified that they need to discontinue patients from the capravirine/placebo arms and continue patients with their background therapies or switch patients to new therapies, as deemed appropriate by the investigators.] Patients are randomized to receive Viracept plus Combivir plus either AG1549 or placebo. Patients remain on their assigned therapy for 48 weeks with one post-therapy follow-up visit. Blood samples are taken regularly to quantify plasma HIV-1 RNA, CD4 and CD8 counts, and peripheral blood mononuclear cells (PBMC). Physical exams, safety assessments, and other tests are also done throughout the study. A blood sample is taken at baseline (pre-dose) for a pharmacokinetics assessment. On Day 8 and at the end of Weeks 4, 8, 16, 24, 36, and 48, pharmacokinetic sampling is done prior to dosing and between 2 to 4 hours post-dose.

Phase II
Interventional
Treatment, Double-Blind, Efficacy Study
HIV Infections
  • Drug: Lamivudine/Zidovudine
  • Drug: Capravirine
  • Drug: Nelfinavir mesylate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Suspended
350
 
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Dominican Republic,   Puerto Rico
 
NCT00004999
 
286C, AG1549-504
Agouron Pharmaceuticals
 
 
NIH AIDS Clinical Trials Information Service
March 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP