A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients

Pharmacia & Upjohn

Status: Completed

Conditions: HIV Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002236

228G

M/3331/0072

Details and patient eligibility

About

The purpose of this study is to see whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.

Full description

Patients are divided into 2 treatment groups; the groups are balanced with respect to viral load. Group A receives ZDV, DLV, and IDV 3 times daily. Group B receives ZDV, DLV, and IDV 2 times daily. Patients are evaluated for changes from baseline in viral load and CD4 cell count.

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.
• Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml.
• Have a CD4 cell count of at least 50 cells/mm3.
• Are at least 14 years old (consent of parent or guardian is required if under 18).

Exclusion Criteria

You will not be eligible for this study if you:

• Have ever taken an anti-HIV drug other than ZDV.
• Have taken ZDV for more than 1 month.