Clinical Trials

MainTitle

A Study of Viracept in HIV-Positive Women

This study has been completed
Sponsor
Agouron Pharmaceuticals


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002171

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: May 1999
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Nelfinavir mesylate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002171

Locations

United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Univ of Southern California / LA County USC Med Cntr
Los Angeles, California, United States, 90033
United States, Louisiana
HIV Outpatient Clinics / LA State Univ Med Ctr
New Orleans, Louisiana, United States, 70112
United States, Texas
Baylor Univ
Houston, Texas, United States, 77009

Sponsors and Collaborators

Agouron Pharmaceuticals
More Information

More Information


Responsible Party: Agouron Pharmaceuticals  
ClinicalTrials.gov Identifier: NCT00002171   History of Changes  
Other Study ID Numbers: 259D  
  Study 534  
  AG1343 - 534  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Placebos
Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors
Lamivudine
Nelfinavir
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
HIV Seropositivity
Nelfinavir

ClinicalTrials.gov processed this data on September 16, 2019
This information is provided by ClinicalTrials.gov.