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

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

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.

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.