A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients

Pharmacia and Upjohn160 enrolled

Overview

The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).

In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks: Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC\*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC. * Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

160

Conditions

HIV Infections

Interventions

Indinavir sulfateDRUG

Delavirdine mesylateDRUG

LamivudineDRUG

ZidovudineDRUG

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria Prior Medication: Allowed: Less than 1 month prior treatment with zidovudine. Exclusion Criteria Prior Medication: Excluded: * Prior indinavir. * Prior lamivudine. * Prior protease inhibitors. * Prior non-nucleoside reverse transcriptase inhibitors. * 1 month or more prior zidovudine. 1\. HIV-1 positive. * CD4 coun tis above 50. * HIV-1 RNA levels greater than 20,000.

Locations (1)

Pharmacia & Upjohn

Peapack, New Jersey, United States

Data from ClinicalTrials.gov

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