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

Pharmacia & Upjohn

Status: Completed

Conditions: HIV Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002401

0074

228F

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.