NCT00751153

Raltegravir and Atazanavir Replacing Current Suppressive Treatment Because of Side Effects in Current Treatment

Open Label Phase 4, 48 Week Pilot Study of the Antiviral Efficacy and Tolerability of the Combination of Isentress™ and ReyatazTM When Substituted for Current Antiviral Regimen in Patients With Viral Suppression But Who Are Experiencing Adverse Events Related to Their Current Antiviral Regimen.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Peter J. Ruane, M.D., Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Subjects with HIV who have viral suppression on current regimen but also have side effects/intolerance will change their current regimen to a combination of Raltegravir and Atazanavir and be monitored for viral and immunological response and quality of life.

Detailed description

Subjects with intolerance to current regimen will receive Raltegravir 400 mg twice daily and Atazanavir 400 mg daily will be monitored for viralogical and immunological outcomes, changes in lipids, renal and hepatic safety and quality of life.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Raltegravir and Atazanavir	Rategravir 400 BID, Atazanavir 400 mg daily

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-10-01
• Completion: 2009-12-01
• First posted: 2008-09-11
• Last updated: 2008-10-09

Locations

1 site across 1 country: United States