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

Pharmacia & Upjohn

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Indinavir sulfate; Drug: Zidovudine; Drug: Delavirdine mesylate; Drug: Lamivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002400

0063

228C

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.