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Clinical Trials

MainTitle

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

The recruitment status of this study is unknown.

Verified May 2011

Sponsor
Central Institute of Epidemiology, Moscow, Russia

Collaborator
Merck Sharp & Dohme Corp.

Information provided by (Responsible Party)
Central Institute of Epidemiology, Moscow, Russia
ClinicalTrials.gov Identifier
NCT01059422

First received: January 28, 2010
Last updated: May 5, 2011
Last Verified: May 2011
History of Changes
Purpose

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: 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

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)

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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

More Information


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  

Additional relevant MeSH terms:
HIV Infections
Tuberculosis
Lamivudine
Abacavir
Dideoxynucleosides
Raltegravir Potassium

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.