Back to resultsA Study of Viracept in HIV-Positive Women
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nelfinavir mesylate
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Placebos, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Lamivudine, Nelfinavir, Anti-HIV Agents
Eligibility 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.
Sites / Locations
- Univ of Alabama at Birmingham
- Univ of Southern California / LA County USC Med Cntr
- HIV Outpatient Clinics / LA State Univ Med Ctr
- Baylor Univ
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002171
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Agouron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00002171
Brief Title
A Study of Viracept in HIV-Positive Women
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 Type
Interventional
2. Study Status
Record Verification Date
May 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Agouron Pharmaceuticals
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Placebos, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Lamivudine, Nelfinavir, Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Univ of Southern California / LA County USC Med Cntr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
HIV Outpatient Clinics / LA State Univ Med Ctr
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Baylor Univ
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Viracept in HIV-Positive Women
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