A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml

Patrocinadores

Patrocinador principal: Bristol-Myers Squibb

Fuente Bristol-Myers Squibb
Resumen breve

To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.

Descripción detallada

100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).

Patients will be treated for 48 weeks.

Estado general Completed
Fase N/A
Tipo de estudio Interventional
Inscripción 200
Condición
Intervención

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

Tipo de intervención: Drug

Nombre de intervención: Zidovudine

Elegibilidad

Criterios:

Inclusion Criteria

Patients must have:

- Documented HIV infection.

- CD4 cell count of 200 - 700 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

AIDS defining condition within 1 month of study entry.

Prior Medication:

Excluded:

Patients with any history of antiretroviral therapy treatment.

Género: All

Edad mínima: 16 Years

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones:
Univ of Alabama at Birmingham | Birmingham, Alabama, 35294, United States
HIV Clinical Research Ctr | Fort Lauderdale, Florida, 33316, United States
Infectious Disease Research Institute Inc | Tampa, Florida, 33614, United States
Advance Clinical Research | Atlanta, Georgia, 30327, United States
Louisiana State Univ Med Ctr / HIV Outpatient Clinic | New Orleans, Louisiana, 70112, United States
Boston Univ Med Ctr Hosp / Evans - 556 | Boston, Massachusetts, 02118, United States
Community Research Initiative of New England | Brookline, Massachusetts, 02445, United States
Washington Univ School of Medicine | St Louis, Missouri, 63108, United States
Blackstock Family Health Ctr | Austin, Texas, 76751, United States
Hosp Regional de Ponce - Area Vieja | Ponce, 00731, Puerto Rico
San Juan AIDS Program | Santurce, 00908, Puerto Rico
Ubicacion Paises

Puerto Rico

United States

Fecha de verificación

October 2007

Palabras clave
Condición Examinar
Información de diseño del estudio

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Fuente: ClinicalTrials.gov