Raltegravir + Lamivudine/Abacavir in HIV/Tuberculosis Co-Infected Patients
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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 hiv-infections
Started Oct 2010
Typical duration for phase_4 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2010
CompletedFirst Posted
Study publicly available on registry
January 29, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedAugust 29, 2024
August 1, 2024
2.4 years
January 28, 2010
August 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects with plasma HIV-1 RNA <50 copies/ml by the Time to Loss of Virologic Response (TLOVR) algorithm
It's included in the primary outcome measure title.
48 week
Study Arms (1)
Raltegravir; Abacavir/Lamivudine
EXPERIMENTALRaltegravir: 400 mg twice daily Abacavir/Lamivudine fixed-dose combination: 600mg/300mg once daily
Interventions
Raltegravir: 400 mg twice daily Abacavir/Lamivudine fixed-dose combination: 600mg/300mg once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central Research Institute of Epidemiology
Moscow, 111123, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vadim V. Pokrovsky, PhD
Central Research Institute of Epidemiology
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 28, 2010
First Posted
January 29, 2010
Study Start
October 1, 2010
Primary Completion
March 1, 2013
Study Completion
May 1, 2013
Last Updated
August 29, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share