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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01059422
• Other study ID #: RAL/ABC/3TC - HIV/TB
• Status: Recruiting
• Phase: Phase 4
• First received: January 28, 2010
• Last updated: May 5, 2011
• Start date: October 2010

Study information

• Verified date: May 2011
• Source: Central Institute of Epidemiology, Moscow, Russia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Tuberculosis

Intervention

Drug:
• Raltegravir; Abacavir/Lamivudine
Raltegravir: 400 mg twice daily Abacavir/Lamivudine fixed-dose combination: 600mg/300mg once daily

Locations

Country	Name	City	State
Russian Federation	Central Research Institute of Epidemiology	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Central Institute of Epidemiology, Moscow, Russia	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with plasma HIV-1 RNA <50 copies/ml by the Time to Loss of Virologic Response (TLOVR) algorithm		48 week	No