NCT00632970

Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals

A Multi-Center Comparison of Raltegravir to Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV-Infected Individuals Naive to Antiretroviral Therapy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: George Washington University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada.

Detailed description

It is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in CD4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Raltegravir	1, 400mg tablet twice a day, with Truvada 1 tablet once a day
DRUG	Lopinavir/Ritonavir	2 tablets twice a day, with Truvada 1 tablet once a day
DRUG	Truvada	1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-02-01
• Completion: 2010-06-01
• First posted: 2008-03-11
• Last updated: 2018-08-29
• Results posted: 2017-06-26

Locations

1 site across 1 country: United States