Raltegravir + Lamivudine/Abacavir in HIV/Tuberculosis Co-Infected Patients

Efficacy and Safety of an Initial Regimen Raltegravir (RAL) + Lamivudine/Abacavir Fixed-Dose Combination (3TC/ABC FDC) for 48 Weeks in ART-naïve, HIV/TB Co-Infected Adult Subjects Receiving Rifabutin-containing, 1-line Anti-TB Therapy

The study will investigate whether combination antiretroviral therapy of raltegravir and 3TC/ABC is effective and safe to use in tuberculosis (TB)/HIV co-infected adults receiving rifabutin-containing, first-line antituberculous treatment.

Hypothesis:Combination antiretroviral therapy of raltegravir and 3TC/ABC and is effective and safe to use in tuberculosis (TB)/HIV co-infected adults receiving rifabutin-based first-line antituberculous treatment.

Study Overview

• Status: Unknown
• Conditions: HIV Infections; Tuberculosis
• Intervention / Treatment: Drug: Raltegravir; Abacavir/Lamivudine

Detailed Description

This is a phase IIIB/IV, open-label, multi-center, single-arm descriptive pilot study of the efficacy and safety of RAL BID in combination with ABC/3TC QD in antiretroviral-naïve HIV-1 infected individuals with a presumptive or confirmed diagnosis of tuberculosis, without planned comparative analyses.

A goal of 40 subjects will be enrolled from 3 sites in the Russian Federation, including in our site, and receive RAL BID + 3TC/ABC QD for 48 weeks.

This study will include screening, treatment and follow-up periods. Screening period up to 28 days includes initial visits at Day -28 (screening) and Day -14 (switch to rifabutin). The second visit will be required if patient is initially on rifampin-based TB regimen that will need to be switched to rifabutin-based regimen.

Patients receiving rifampin-containing TB therapy will be switched to rifabutin (300 mg daily) a minimum of 14 days prior to initiation of antiretroviral therapy. Patients must not have received more than 45 days of tuberculosis therapy.

Treatment period from Day 1 to Week 48 includes 7 visits and a follow-up period (2-4 weeks after the Week 48 visit or Withdrawal visit) includes one visit for resolution of ongoing AEs and new SAEs. Patients will therefore have 10 scheduled assessments: screening (Day -28; Day -14), baseline (Day 1), Weeks 4, 8, 12, 24, 36, and 48, and follow-up visit.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 111123
    • Recruiting
    • Central Research Institute of Epidemiology
    • Contact: Alexey V. Kravtchenko, PhD; Phone Number: +74953660518; Email: alexey-kravtchenko@yandex.ru
    • Sub-Investigator: Alexey V. Kravtchenko, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ART-naïve HIV infected patients
• Plasma HIV-1 RNA >1,000 copies/mL at screening
• CD4 cells 100-350 cells/mm3
• Have presumptive or confirmed diagnosis of Mycobacterium tuberculosis infection
• Receiving first-line antituberculosis treatment
• Documented negative results for the presence of HLA-B*5701 allele

Exclusion Criteria:

• Pregnancy and Breastfeeding
• Known allergy/sensitivity to study drugs or their formulations
• A condition (including but not limited to active alcohol or drug use) that, in the opinion of the investigator, may interfere with patient adherence or safety

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with plasma HIV-1 RNA <50 copies/ml by the Time to Loss of Virologic Response (TLOVR) algorithm	48 week

Collaborators and Investigators

• Sponsor: Central Institute of Epidemiology, Moscow, Russia
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Vadim V. Pokrovsky, PhD, Central Research Institute of Epidemiology

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: January 28, 2010
• First Submitted That Met QC Criteria: January 28, 2010
• First Posted (Estimate): January 29, 2010

Study Record Updates

• Last Update Posted (Estimate): May 6, 2011
• Last Update Submitted That Met QC Criteria: May 5, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Raltegravir Potassium; Lamivudine; Abacavir
• Other Study ID Numbers: RAL/ABC/3TC - HIV/TB