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

NCT00654147 | Completed Phase 2 Results DMC

• 1 other identifier: A009
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; antiretroviral therapy naive; Integrase inhibitor; HIV/AIDS; treatment naïve

Outcome Measures

Primary Outcomes (2)

• Time to Confirmed Virologic Failure

  time to confirmed viologic failure at 24 weeks (up to 48 weeks)

  weeks

• Time to Virologic Failure

  time to virologic failure at week 24 (up to 48 weeks)

  week 24 (up to 48 weeks)

Secondary Outcomes (4)

• Study Medication Toxicity-related Discontinuation .

  48 weeks

• Weeks to HIV-1 RNA <200 Copies/ml

  from date of treatment start to first week documented viral suppression

• Change From Baseline CD4+ and CD8+ Cell Counts

  Baseline, Weeks 16 and 24

• Study Medication Tolerability

  date started study treatment to first week documented change study treatment up to week 48

Study Arms (2)

Raltegravir & Lopinavir/ritonavir

ACTIVE COMPARATOR

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

Drug: Raltegravir & Lopinavir/ritonavir

Raltegravir & emtricitabine/tenofovir

ACTIVE COMPARATOR

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

Drug: Raltegravir and emtricitabine/tenofovir

Interventions

Raltegravir & Lopinavir/ritonavir DRUG

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

Also known as: Isentress, Kaletra

Raltegravir & Lopinavir/ritonavir

Raltegravir and emtricitabine/tenofovir DRUG

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

Also known as: Isentress, Truvada

Raltegravir & emtricitabine/tenofovir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Margaret A. Fischl, M.D.: lead

Study Sites (1)

University of Miami AIDS Clinical Research Unit

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Raltegravir Potassium; Lopinavir; Ritonavir; lopinavir-ritonavir drug combination; Emtricitabine; Tenofovir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Pilot study with 44 subjects and generalization f results is limited by the small sample size.

Results Point of Contact

• Title: Director AIDS Clinical Research Unit
• Organization: University of Miami School of Medicine

mfischl@med.miami.edu

305-243-3838

Study Officials

• Margaret A Fischl, M.D.

  University of Miami AIDS Clinical Research Unit

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, Director AIDS Clinical Research Unit

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: August 3, 2015
• Results First Posted: July 13, 2015

Record last verified: 2015-07

Locations

US (1)