Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects

NCT ID: NCT00654147

Last Updated: 2015-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2012-01-31

Brief Summary

A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the protease inhibitor lopinavir/ritonavir (LPV/r) and a three drug regimen with Raltegravir and two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.

Immunology Substudy added to determine the kinetics of recovery of CD4 T cells and subpopulations (regulatory T cell [T regs], TH-17 and TH1) after treatment initiation with Raltegravir based regimens and their relationship with functional CD8 T cells and if Raltegravir containing therapies leads to decreases in markers of gut microbial translocation and of cellular and soluble markers of immune activation.

Detailed Description

A009 is a prospective, randomized, open-label pilot study to assess virologic suppression and immune recovery rates associated with a two-drug potent antiretroviral regimen of raltegravir and the protease inhibitor lopinavir/ritonavir and a three-drug regimen with raltegravir and two nRTIs (emtricitabine/tenofovir) in treatment-naïve subjects.

HIV-1-infected subjects who are antiretroviral drug-naïve and have plasma HIV-1 RNA levels ≥5000 copies/ml obtained within 30 days prior to study entry will be randomized 1:1 to Raltegravir 400 mg BID + LPV 400 mg/RTV 100 mg BID (Arm A) or Raltegravir 400 mg BID + FTC 200 mg/TDF 300 mg QD (Arm B).

Subjects will have measurements of HIV-1 RNA and CD4+ and CD8+ T-cell counts at pre-entry and entry. The average of these measurements will be used to establish their baseline values. Following entry, subjects will have plasma HIV-1 RNA samples drawn at days 2, 4, 8 and at weeks 2, 4, 8, 16, 24, 32, 40 and 48 and at virologic failure. CD38 expression on CD4+/CD8+ cells and CD38/HLA-DR activation antigen on CD4+ and CD8+ cells and subsets T-cell percentage will be done at entry, day 8 and weeks 4, 8, 24 and at virologic failure by advanced flow cytometry.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Raltegravir & Lopinavir/ritonavir

Raltegravir 400 mg tablet and Lopinavir/ritonavir capsule by mouth, every 12 hours for 48 weeks

Group Type: ACTIVE_COMPARATOR

Raltegravir & Lopinavir/ritonavir

Intervention Type: DRUG

Two drug regimen of an integrase inhibitor and ritonavir boosted protease inhibitor

Raltegravir & emtricitabine/tenofovir

Raltegravir 400 mg tablet bu mouth, every 12 hours for 48 weeks and tenofovir/embritcitabine 200 mg/100 mg table by mouth, once daily for 48 weeks

Group Type: ACTIVE_COMPARATOR

Raltegravir and emtricitabine/tenofovir

Intervention Type: DRUG

Three drug regimen of an integrase inhibitor and a fixed dose combination of a non-nucleoside/nucleotide inhibitors

Interventions

Raltegravir & Lopinavir/ritonavir

Two drug regimen of an integrase inhibitor and ritonavir boosted protease inhibitor

Intervention Type: DRUG

Raltegravir and emtricitabine/tenofovir

Three drug regimen of an integrase inhibitor and a fixed dose combination of a non-nucleoside/nucleotide inhibitors

Intervention Type: DRUG

Other Intervention Names

Isentress; Kaletra; Isentress; Truvada

Eligibility Criteria

Inclusion Criteria

• Documented HIV Infection
• Genotypic resistance without major resistance mutations within 30 days
• Antiretroviral drug-naïve
• Screening HIV-1 RNA ≥5000
• Women of reproductive potential
• Negative pregnancy test within 48 hours

Exclusion Criteria

• Acute or recent HIV-1 infection
• Currently breast feeding
• Use of immunomodulators
• Evidence of major resistance mutations
• HBsAg positive
• Acute hepatitis of any etiology or clinically significant liver disease
• Current imprisonment or involuntary incarceration

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Margaret A. Fischl, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Margaret A. Fischl, M.D.

Professor of Medicine, Director AIDS Clinical Research Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Margaret A Fischl, M.D.

Role: STUDY_CHAIR

University of Miami AIDS Clinical Research Unit

Locations

University of Miami AIDS Clinical Research Unit

Miami, Florida, United States

Countries

United States

Other Identifiers

A009

Identifier Type: -

Identifier Source: org_study_id