Status:
COMPLETED
Standard Versus Double Dose Dolutegravir in Patients With HIV-associated Tuberculosis
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
Wellcome Trust
Medecins Sans Frontieres, Netherlands
Conditions:
HIV Infections
Tuberculosis
Eligibility:
All Genders
18-110 years
Phase:
PHASE2
Brief Summary
The investigators propose to conduct a phase 2 randomised (1:1) double-blind placebo-controlled trial of the dolutegravir-lamivudine-tenofovir fixed dose combination tablet daily with an additional 50...
Detailed Description
Dolutegravir is being rolled out to replace efavirenz in first-line antiretroviral therapy (ART) in low-middle income countries (LMICs) because it is more effective, better tolerated, and has a consid...
Eligibility Criteria
Inclusion
- HIV-1 infection as documented by screening plasma HIV-1 RNA \>1000 c/mL
- ART-naïve (short-term antiretroviral use for prevention of mother-to-child transmission will be allowed) or
- ART treatment interrupters on ART \<6 months prior to interruption or virologically suppressed (\<50 copies/mL or LDL) \<6 months prior to interruption
- On rifampicin-based therapy for tuberculosis for \<3 months
- CD4 counts \>100 cells/µL
- Women of child-bearing potential willing to use adequate contraception (defined as either an intrauterine contraceptive device or hormonal contraception as per national guidelines)
Exclusion
- Pregnant/breastfeeding
- Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 (calculated by the Modification of Diet in Renal Disease (MDRD) study)
- Alanine aminotransferase \>3 times upper limit of normal (ULN)
- Allergy or intolerance to one of the drugs in regimen
- Concomitant medication known to significantly reduce or increase dolutegravir exposure (except rifampicin)
- Active psychiatric disease or substance abuse
- On treatment for active AIDS-defining condition other than tuberculosis (participants on maintenance therapy may be enrolled)
- Malignancy
- Any other clinical condition that in the opinion of an investigator puts the patient at increased risk of participating in the study.
Key Trial Info
Start Date :
December 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2022
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03851588
Start Date
December 19 2019
End Date
June 28 2022
Last Update
July 18 2024
Active Locations (1)
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1
Khayelitsha Site B/Ubuntu Clinic
Cape Town, Western Cape, South Africa, 8001