A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients

Pharmacia and Upjohn45 enrolled

Overview

The purpose of this study is to compare the safety and effectiveness of giving HIV-infected patients delavirdine (DLV) plus zidovudine (ZDV) plus 2 doses of indinavir (IDV) or ZDV plus IDV plus lamivudine (3TC). This study also examines how the body processes DLV when it is given in combination with other drugs.

In this multicenter, open-label study, 45 HIV-1-positive patients receive either combination drug therapy with delavirdine (DLV), zidovudine (ZDV), and indinavir (IDV) or combination drug therapy with ZDV, lamivudine (3TC), and IDV. NOTE: Patients are treated for 24 weeks and may opt to continue on study for 24 additional weeks, if HIV-1 RNA is less than 5,000 copies/ml or at the investigator's discretion.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

HIV Infections

Interventions

Indinavir sulfateDRUG

Delavirdine mesylateDRUG

LamivudineDRUG

ZidovudineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients must have: * HIV-1 positive. * CD4 count above 50. * HIV-1 RNA greater than 20,000. Prior Medication: Allowed: Less than 1 month prior treatment with zidovudine. Exclusion Criteria Prior Medication: Excluded: * Prior 3TC, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors. * Prior ZDV of greater than 1 month total duration. Prior Treatment: Excluded: * Lamivudine. * Protease inhibitors. * Non-nucleoside reverse transcriptase inhibitors.

Locations (1)

Pharmacia & Upjohn

Peapack, New Jersey, United States

Data from ClinicalTrials.gov

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