A Study of Viracept in HIV-Positive Women
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Nelfinavir mesylate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Agouron Pharmaceuticals
Summary
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.
Clinical Details
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
Study design: Treatment, Placebo Control, Pharmacokinetics Study
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Univ of Southern California / LA County USC Med Cntr, Los Angeles, California 90033, United States
HIV Outpatient Clinics / LA State Univ Med Ctr, New Orleans, Louisiana 70112, United States
Baylor Univ, Houston, Texas 77009, United States
Additional Information
Last updated: June 23, 2005
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