A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs

Weill Medical College of Cornell University

Overview

The purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to HIV-infected patients who have never been treated with anti-HIV drugs.

In this open-label, strategic study patients are evaluated at Weeks 0, 1, 2, 4, 8, 12 to Week 48 after being treated on one of the following regimens: Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

HIV Infections

Interventions

Indinavir sulfateDRUG

NevirapineDRUG

LamivudineDRUG

StavudineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients must have: * Diagnosed asymptomatic HIV infection. * HIV-1 RNA greater than 500 copies/ml. * CD4+ T-cell count greater than 200/mm3. * Never received antiretroviral therapy. Exclusion Criteria Co-existing Condition: Excluded: Severe non-HIV-related disease. Patients with the following prior conditions are excluded: History of neuropathy. Prior Medication: Excluded: * Investigational drug within 1 month prior to study. * Immunomodulatory drug within 1 month prior to study. Prior Treatment: Excluded: * Radiation therapy within past month. * Chemotherapy within past month.

Locations (1)

Cornell AIDS Clinical Trials Unit

New York, New York, United States

Data from ClinicalTrials.gov

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