A Study of Viracept in HIV-Positive Women

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002171
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1999

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002171 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of Viracept in HIV-Positive Women
A Phase II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Viracept in Combination With Antiretroviral Therapy in HIV Positive Women With <= 1 Month of Prior Treatment With d4T and/or 3TC

The purpose of this study is to see if it is safe and effective to give Viracept plus stavudine (d4T) plus lamivudine (3TC) to HIV-positive women with a CD4 count <= 400 cells/mm3. This study also examines how the body handles Viracept when given with d4T and 3TC.

Not Provided
Interventional
Phase 2
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
HIV Infections
Drug: Nelfinavir mesylate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

Inclusion Criteria

Patients must have:

  • HIV infection.
  • CD4 T cell count <= 400 cells/mm3.

Exclusion Criteria

Prior Medication:

Excluded:

  • Prior therapy or less than 1 month of therapy with d4T and/or 3TC.
  • Prior protease inhibitor therapy.
Female
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002171
259D, Study 534, AG1343 - 534
Not Provided
Not Provided
Agouron Pharmaceuticals
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
May 1999

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