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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002171
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

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.

Interventions

DRUGNelfinavir mesylate

Sponsors

Agouron Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Age
13 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026