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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01059422
Recruitment Status : Unknown
Verified May 2011 by Central Institute of Epidemiology, Moscow, Russia.
Recruitment status was:  Recruiting
First Posted : January 29, 2010
Last Update Posted : May 6, 2011
Merck Sharp & Dohme Corp.
Information provided by:
Central Institute of Epidemiology, Moscow, Russia

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
HIV Infections Tuberculosis Drug: Raltegravir; Abacavir/Lamivudine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2010
Estimated Primary Completion Date : October 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Raltegravir; Abacavir/Lamivudine
    Raltegravir: 400 mg twice daily Abacavir/Lamivudine fixed-dose combination: 600mg/300mg once daily
    Other Names:
    • Isentress®
    • Epzicom®

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01059422

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Russian Federation
Central Research Institute of Epidemiology Recruiting
Moscow, Russian Federation, 111123
Contact: Alexey V. Kravtchenko, PhD    +74953660518   
Sub-Investigator: Alexey V. Kravtchenko, PhD         
Sponsors and Collaborators
Central Institute of Epidemiology, Moscow, Russia
Merck Sharp & Dohme Corp.
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Principal Investigator: Vadim V. Pokrovsky, PhD Central Research Institute of Epidemiology

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Responsible Party: Alexey Kravtchenko/Professor, Central Institute of Epidemiology, Moscow, Russia Identifier: NCT01059422     History of Changes
Other Study ID Numbers: RAL/ABC/3TC - HIV/TB
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: May 6, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Raltegravir Potassium
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors