Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Activity of Indinavir Sulfate 1200 Mg q.d. and Ritonavir 200 Mg q.d. in Combination With Stavudine and Lamivudine in Treatment Naive HIV-1 Infected Patients

Patrocinadores

Patrocinador principal: Merck Sharp & Dohme Corp.

Fuente NIH AIDS Clinical Trials Information Service
Resumen breve

The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV) in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have never received anti-HIV therapy. This study will look at the effectiveness of this drug combination and side effects.

Descripción detallada

Patients entering this study initiate antiretroviral therapy. For 24 weeks patients receive daily dosages of IDV, RTV, 3TC, and d4T. Patients are seen at Day 1 and at Weeks 2, 4, 8, 12, 16, 20, and 24 for physical examinations, pregnancy testing, and blood sampling to monitor CD4 count and viral load. On Day 14, blood is drawn frequently for 24 hours for IDV and RTV pharmacokinetic sampling. The incidence of serious and drug-related adverse events and of adverse events leading to study discontinuation is tabulated.

Estado general Unknown status
Fase Phase 2
Tipo de estudio Interventional
Inscripción 8
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Indinavir sulfate

Tipo de intervención: Drug

Nombre de intervención: Ritonavir

Tipo de intervención: Drug

Nombre de intervención: Lamivudine

Tipo de intervención: Drug

Nombre de intervención: Stavudine

Elegibilidad

Criterios:

Inclusion Criteria

Patients may be eligible for this study if they:

- Are HIV-positive.

- Are at least 18 years old.

- Have a viral load of 5,000 copies/ml or greater.

- Have a CD4 count of at least 50 cells/mm3.

Exclusion Criteria

Patients will not be eligible for this study if they:

- Have taken any antiretroviral (anti-HIV) agent.

- Are pregnant.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones:
Univ of Miami School of Medicine | Miami, Florida, 33136, United States
Albany Med College | Albany, New York, 12208, United States
SUNY at Stony Brook / Division of Infectious Diseases | Stony Brook, New York, 11794, United States
Ubicacion Paises

United States

Fecha de verificación

July 2002

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Propósito primario: Treatment

Fuente: ClinicalTrials.gov