NCT00562510

Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery

A Phase 3, Randomized, Double Blinded, Placebo Controlled Study of Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pedro Cahn · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, randomized, double blinded, placebo-controlled study designed to compare the safety, tolerability, antiviral activity and immunological effect of raltegravir added to a previously stable HAART regimen in the treatment of HIV-1 infected subjects with undetectable viraemia and low CD4 recovery. HYPOTHESIS: Adding raltegravir to a stable HAART in patients with undetectable plasma viral load and low CD4 recovery will result in further viral suppression and therefore higher CD4 recovery.

Detailed description

Although HAART has reduced the morbidity and mortality from HIV-1 infection, some patients experience a discordant response characterized by HIV-1 RNA plasma levels below the limit of detection and low CD4 T-cell recovery (immunologic discordant responders). At present, recommendations for the clinical management of patients with discordant responses to antiretroviral therapy are largely based on observational, uncontrolled data. The effect on CD4 count of adding raltegravir in already undetectable patients has not yet been evaluated. The primary purpose of this study is to assess the ability of the HIV-1 integrase inhibitor, raltegravir, added to a stable HAART, to increase CD4 count in patients with undetectable plasma viral load and low CD4 recovery.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Raltegravir	Raltegravir 400 mg BID added to stable HAART
DRUG	Placebo	Placebo BID added to stable HAART

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-11-22
• Last updated: 2015-06-09

Locations

1 site across 1 country: Argentina