drugset / Trial / NCT01204905

R5 Integrase Study in HIV-1 Naive Patients

NCT01204905

NaSingle-groupOpen-labelTreatment

Summary

This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads \> 5,000. The subjects will be followed for 48 weeks. The combination of these two agents has the potential to be a potent regimen with minimal metabolic complications. However, they have not been studied in combination previously. This pilot study proposes to evaluate this combination in antiretroviral naïve patients to document the safety and efficacy of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications.

Timeline

Start
2010-09
Primary completion
2014-05-16
Completion
2014-05-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Maraviroc Other / unclassified 300 mg Oral
Subject Raltegravir Other / unclassified 400 mg Oral