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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Central Institute of Epidemiology, Moscow, Russia.
Recruitment status was:  Recruiting
Merck Sharp & Dohme Corp.
Information provided by:
Central Institute of Epidemiology, Moscow, Russia Identifier:
First received: January 28, 2010
Last updated: May 5, 2011
Last verified: May 2011

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 Intervention Phase
HIV Infections Tuberculosis Drug: Raltegravir; Abacavir/Lamivudine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Central Institute of Epidemiology, Moscow, Russia:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: October 2010
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Raltegravir; Abacavir/Lamivudine
    Raltegravir: 400 mg twice daily Abacavir/Lamivudine fixed-dose combination: 600mg/300mg once daily
    Other Names:
    • Isentress®
    • Epzicom®
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01059422

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.
Principal Investigator: Vadim V. Pokrovsky, PhD Central Research Institute of Epidemiology
  More Information

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
Study First Received: January 28, 2010
Last Updated: May 5, 2011

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
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
Antimetabolites processed this record on September 21, 2017