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

Condition(s) targeted: HIV Infections

Intervention: Indinavir sulfate (Drug); Delavirdine mesylate (Drug); Lamivudine (Drug); Zidovudine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pharmacia and Upjohn

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.

Official title: An Open-Label Randomized Study of Delavirdine Mesylate (Rescriptor) in Combination With Zidovudine (Retrovir) and Two Doses of Indinavir (Crixivan) Versus Zidovudine, Lamivudine (Epivir), and Indinavir in HIV-1-Infected Individuals

Study design: Treatment, Safety Study

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Pharmacia & Upjohn, Peapack, New Jersey 07977, United States

Last updated: June 23, 2005