NCT00002213

The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients With HIV Who Developed a Resistance to Protease Inhibitors

A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy With 1592U89, 141W94 and DMP 266 in HIV-1 Infected Subjects With Detectable HIV-1 Plasma RNA Despite Treatment With a Protease Inhibitor Containing Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (planned)
• Sponsor: Glaxo Wellcome · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if it is safe and effective to give 1592U89 plus 141W94 plus DMP 266 to patients with HIV who have developed resistance to indinavir, ritonavir, saquinavir, or nelfinavir after at least 20 weeks of protease inhibitor treatment. This study also examines how long this combination therapy is effective before patients develop resistance to it.

Detailed description

This is a multicenter, open-label study. A total of 80 patients are treated on this study and include: At least 30 patients with a viral burden of 500 - 40,000 copies/ml. At least 30 patients with a viral burden greater than 40,000 copies/ml. At least 20 patients with less than 1 year total prior treatment with nucleoside reverse transcriptase inhibitors (NRTIs). All patients receive self-administered, combination antiretroviral therapy for 48 weeks, as follows: 1592U89 plus 141W94 plus DMP 266.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Abacavir sulfate
DRUG	Amprenavir
DRUG	Efavirenz

Timeline

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

Locations

9 sites across 1 country: United States