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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Central Institute of Epidemiology, Moscow, Russia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Central Institute of Epidemiology, Moscow, Russia
ClinicalTrials.gov Identifier:
NCT01059422
First received: January 28, 2010
Last updated: May 5, 2011
Last verified: May 2011
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01059422

Locations
Russian Federation
Central Research Institute of Epidemiology Recruiting
Moscow, Russian Federation, 111123
Contact: Alexey V. Kravtchenko, PhD    +74953660518    alexey-kravtchenko@yandex.ru   
Sub-Investigator: Alexey V. Kravtchenko, PhD         
Sponsors and Collaborators
Central Institute of Epidemiology, Moscow, Russia
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Vadim V. Pokrovsky, PhD Central Research Institute of Epidemiology
  More Information

No publications provided

Responsible Party: Alexey Kravtchenko/Professor, Central Institute of Epidemiology, Moscow, Russia
ClinicalTrials.gov 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
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lamivudine
Abacavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 18, 2014