NCT00002199

A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 550 (planned)
• Sponsor: Glaxo Wellcome · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC, defined class B/C events, survival, medical resource utilization, and the development of plasma viral genotypic and phenotypic resistance.

Detailed description

In this international study, 550 patients are randomized (225 per arm) to receive Combivir in combination with 1592U89 or indinavir. If after 16 weeks (and every 8 weeks thereafter until week 48) a patient has HIV-1 RNA \>= 400 copies/ml (by PCR on two occasions \>= 1 week and \< 4 weeks apart), the patient has the option to switch to open-label therapy consisting of indinavir, 1592U89, and Combivir.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Indinavir sulfate
DRUG	Lamivudine/Zidovudine
DRUG	Abacavir sulfate

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States