A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine

A Multicenter, Double-Blind, Randomized Pilot Study to Compare the Safety and Activity of L-756423/Indinavir, 1600/800 Mg Qd or 800/400 Mg Bid Versus Indinavir, 800 Mg q8h, All in Combination With Stavudine and Lamivudine

Patrocinadores

Patrocinador principal: Merck Sharp & Dohme Corp.

Fuente NIH AIDS Clinical Trials Information Service
Resumen breve

This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.

Descripción detallada

Patients are randomized to 1 of 4 treatment arms. In Group 1, patients receive a dose of L-756423/IDV once daily plus IDV placebo. In Group 3, patients receive a lower dose of L-756423/IDV twice daily (with the daily dosage equaling that of Group 1) plus IDV placebo. In Groups 2 and 4, patients receive equal dosages of IDV plus L-756423/IDV placebo. In all 4 groups L-756423 and IDV are blinded to the investigator and patient. All groups receive open-label d4T and 3TC. Patients routinely undergo a physical exam and have blood and urine tests to ensure the drugs' safety and tolerability, which will be evaluated by tabulation of adverse events and clinical assessment of laboratory data. In addition, CD4+ T cell and plasma viral RNA levels are measured to quantify the drugs' antiretroviral activity.

Estado general Suspended
Fase Phase 2
Tipo de estudio Interventional
Inscripción 186
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: L-756423

Tipo de intervención: Drug

Nombre de intervención: Indinavir sulfate

Tipo de intervención: Drug

Nombre de intervención: Lamivudine

Tipo de intervención: Drug

Nombre de intervención: Stavudine

Elegibilidad

Criterios:

Inclusion Criteria

You may be eligible for this trial if you:

- Have HIV infection.

- Have levels of CD4 cells of 100 cells/mm3 or greater.

- Have a viral load of 10,000 copies/ml or greater.

- Are 18 years of age or older.

Exclusion Criteria

You may not be eligible for this trial if you:

- Have ever taken anti-HIV drugs.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones:
UCLA School of Medicine / Ctr for Research and Education | Los Angeles, California, 900951793, United States
Georgetown Univ Med Ctr | Washington, District of Columbia, 20007, United States
ViRx / Dupont Circle Physicians Group | Washington, District of Columbia, 20009, United States
Associates in Research | Fort Myers, Florida, 33901, United States
Univ of Miami School of Medicine | Miami, Florida, 33136, United States
Grady Mem Hosp | Atlanta, Georgia, 30308, United States
Rush Presbyterian - Saint Luke's Med Ctr | Chicago, Illinois, 60612, United States
The CORE Ctr | Chicago, Illinois, 60612, United States
Univ of Kentucky Med Ctr | Lexington, Kentucky, 40536, United States
Univ of Kentucky | Lexington, Kentucky, 40536, United States
Beth Israel Deaconess Med Ctr | Boston, Massachusetts, 02215, United States
Henry Ford Hosp | Detroit, Michigan, 48202, United States
NYU Med Ctr / C & D Building | New York, New York, 10016, United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ | New York, New York, 10021, United States
SUNY at Stony Brook / Div of Infectious Disease | Stony Brook, New York, 117948153, United States
The Miriam Hosp | Providence, Rhode Island, 02906, United States
Ubicacion Paises

United States

Fecha de verificación

April 2000

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

Propósito primario: Treatment

Enmascaramiento: Double

Fuente: ClinicalTrials.gov