NCT00257621

GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults

A Pilot, Phase II, Open-label, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GW640385 When Administered With Ritonavir in Combination With NRTIs for 48 Weeks in HIV-1 Infected Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI) backbone. This study has a 48 week duration and is open to both treatment naive and experienced patients who are HIV positive. There are 3 intensive pharmacokinetic (PK) visits.

Conditions

• Infection, Human Immunodeficiency Virus I
• HIV Infection

Interventions

Type	Name	Description
DRUG	GW640385
DRUG	Ritonavir

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-11-23
• Last updated: 2017-05-30

Locations

9 sites across 1 country: United States