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

Pharmacia and Upjohn1 site in 1 country160 target enrollmentAugust 31, 2001

ConditionsHIV Infections

DrugsIndinavir sulfate Delavirdine mesylate Lamivudine Zidovudine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Pharmacia and Upjohn
Enrollment: 160
Locations: 1
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

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.

Registry

clinicaltrials.gov

Start Date

August 31, 2001

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Sex

All