Completed

Safety and Efficacy of Viracept, Stavudine (d4T) and Lamivudine (3TC) in HIV-Positive Women

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Nelfinavir mesylate

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorAgouron Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on HIV-positive women who have received limited prior treatment, specifically with d4T and/or 3TC. The main goal is to evaluate the safety and effectiveness of a drug called Viracept when used in combination with antiretroviral therapy, which includes stavudine (d4T) and lamivudine (3TC). The study is particularly interested in women with a CD4 count of less than or equal to 400 cells/mm3. The potential outcomes of this study could offer a new treatment option for HIV-positive women, addressing the ongoing need for effective HIV management strategies. During this study, participants receive a combination of Viracept, d4T, and 3TC. The study examines how the body responds to this combination, including how it processes Viracept when given with d4T and 3TC. This helps researchers understand the safety and effectiveness of this treatment approach. As with any medical study, there may be potential risks and benefits associated with participation.

NCT00002171
Principal SponsorAgouron Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

2 inclusion criteria required to participate
CD4 T cell count <= 400 cells/mm3.
HIV infection.
2 exclusion criteria prevent from participating
Prior therapy or less than 1 month of therapy with d4T and/or 3TC.
Prior protease inhibitor therapy.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

Univ of Southern California / LA County USC Med Cntr

Los Angeles, United States

HIV Outpatient Clinics / LA State Univ Med Ctr

New Orleans, United States

Baylor Univ

Houston, United States
Completed4 Study Centers