A Study of Delavirdine Used Together With Other Anti-HIV Drugs 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 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).

Official title: An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals

Study design: Treatment, Safety Study

Detailed description: 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.

Minimum age: 14 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

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

Last updated: June 23, 2005