INSTI's For The Management of HIV-associated TB (INSIGHT)

  • STATUS
    Recruiting
  • End date
    Oct 4, 2024
  • participants needed
    120
  • sponsor
    Centre for the AIDS Programme of Research in South Africa
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Updated on 17 March 2022
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Summary

This study is being conducted to assess the antiretroviral activity of a fixed-drug, single tablet, combination of Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir alafenamide 25mg (Biktarvy®) dosed twice daily in HIV-1 infected, ART-naïve patients with TB co-infection receiving a rifampicin-based tuberculosis (TB) treatment regimen. This study will assess the activity of Bictegravir and dolutegravir-containing ART regimens in patients with drug-susceptible TB through 48 weeks

Description

Primary objective: To characterize viral suppression rates (proportion of patients with suppressed viral load) at week 24 in the BIC arm

Secondary objectives:

To characterize viral suppression rates at weeks 12, 24 and 48 in the standard of care treatment (SOC) arm (currently, TDF 300mg/3TC 300mg/DTG 50mg) and at weeks 12 and 48 in the BIC/FTC/TAF arm.

To compare the pharmacokinetics (PK) of BIC when given twice daily and co-administered with Rifampicin during tuberculosis treatment vs when given alone after discontinuation of Rifampicin

To assess the incidence of TB associated IRIS in each arm, through week 24.

To characterize the tolerability of treatment in each arm by assessing frequency of clinician-initiated treatment interruptions or switches through week 48.

To assess frequency of ART drug resistance mutations in participants with detectable viral load at study visit weeks 24 and 48.

Details
Condition HIV/AIDS, Tuberculosis, Pulmonary
Treatment Biktarvy®, TLD- fixed-drug combination single tablet
Clinical Study IdentifierNCT04734652
SponsorCentre for the AIDS Programme of Research in South Africa
Last Modified on17 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Adults ≥ 18 years of age with Karnofsky score ≥ 70Confirmed rifampicin-susceptible tuberculosis
On first-line rifampicin-based tuberculosis treatment (not > 8 weeks at the time of enrolment)
Documented HIV-1 infection, ART-naïve
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2
Alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)
Total bilirubin ≤2.5 times ULN
Creatinine ≤2 times ULN
Hemoglobin ≥ 7.0 g/dL (6.5 g/dL for females)
Platelet count ≥ 50,000/mm3
Absolute Neutrophil Count (ANC) ≥650/mm3
Able and willing to provide written informed consent
Female patients agree to use both a barrier and a non-barrier form of contraception during the study, starting at least 14 days prior to enrolment

Exclusion Criteria

Pregnancy or breastfeeding (or planned pregnancy within 12 months of study entry)
Prior use of antiretroviral drugs for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP)
Hepatitis B surface antigen positive, Hepatitis B virus (HBV) infection, active infections (other than HIV-1 infection) requiring systemic antibiotic or antifungal therapy current or within 30 days prior to baseline
Participants with a CD4+ cell count of < 100 cells/ μl
Any verified Grade 4 laboratory abnormality, with the exception of, Grade 4 triglycerides. A single repeat test is allowed during the Screening period to verify a result
Patients on metformin (> 500mg, 12hourly)
Patients with an uncontrolled psychiatric co-morbidity. Patients who, in the investigator's judgment, pose a significant suicidality risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk
Other condition or circumstance deemed by clinician/investigators to be detrimental to patient safety or study conduct
Unwilling to be part of the main pharmacokinetic (PK) study and have PK blood draws done (NB there is a semi-intensive PK substudy which is optional)
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