| 2014 | PREVENT TB |
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Protocol Title |
Safety, tolerability, and drug-drug interactions of short-course treatment of TB preventive therapy with high-dose once-weekly rifapentine (RPT) plus isoniazid or standard of care isoniazid preventative therapy (IPT) among human immunodeficiency virus (HIV)-infected patients taking dolutegravir-based antiretroviral treatment Treatment Indication: Trial Objective: |
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Treatment Indication |
TB preventative therapy (TPT) in persons with HIV infection |
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Trial Objective |
Assess the safety, tolerability, and pharmacokinetics of three months of once-weekly isoniazid and rifapentine (3HP) or 12 months of Isoniazid alone (IPT) among persons taking dolutegravir (DTG) and tenofovir/emtricitabine (TDF/FTC) or tenofovir/lamivudine (TDF/3TC) for HIV infection |
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Trial Design |
Single-arm, single-center, Phase I/II clinical trial, in four groups. |
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Trial Sites |
The Aurum Institute, NPC, South Africa, Clinical Research Division, Tembisa Clinical Research Centre, South Africa |
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Outcome |
Findings: Short Regimen for Preventing TB Found Safe When Co-administered with New First-line HIV Drug |
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Presentation on Findings |
Find the Dolphin One Publication here. Find the Dolphin TOO Report here. |
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Protocol Title |
Safety, tolerability and drug-drug interactions of short-course tuberculosis preventive treatment with high-dose once-weekly rifapentine and isoniazid (3HP) among Infants, Children and Adolescents Living with HIV taking dolutegravir-based antiretroviral treatment |
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Treatment Indication |
TB preventive treatment (TPT) in persons with HIV infection |
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Trial Objective |
Assess the safety, tolerability, and pharmacokinetics of three months of once-weekly isoniazid and rifapentine (3HP) among infants, children and adolescents taking dolutegravir (DTG) and 2 nucleoside reverse transcriptase inhibitors (NRTIs) for HIV infection |
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Trial Design |
Single-arm, multi-center, Phase I/II clinical trial, in two groups. |
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Trial Sites |
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Outcome |
Trial in progress |
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Protocol Title |
Safety and tolerability of 1 month daily (1HP) and 3 months weekly (3HP) isoniazid and rifapentine with pharmacokinetics of dolutegravir (DTG) in pregnant people with HIV |
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Treatment Indication |
TB preventive treatment (TPT) in pregnant people with HIV infection |
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Trial Objective |
Assess the safety and tolerability of one month of 1HP and 3HP with pharmacokinetics of DTG among adult pregnant people taking dolutegravir (DTG) and 2 nucleoside reverse transcriptase inhibitors (NRTIs) for HIV infection |
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Trial Design |
Open-label, two-arm, randomized multicenter study to investigate the safety, tolerability, PK, and potential interactions of DTG and rifapentine (RPT) during pregnancy in people with HIV when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) or weekly for 3 months (3HP) as part of TB preventive therapy. |
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Trial Sites |
Finalized site selection to be determined but anticipated to include :
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Outcome |
Trial approved. Waiting for enrolments |
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Protocol Title |
A Randomized Trial Comparing Treatment Completion of Daily Rifapentine & Isoniazid for One Month (1HP) to Weekly Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in HIV-negative Household Contacts of Recently Diagnosed Tuberculosis Patients, The “One To Three” Trial |
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Treatment Indication |
TB preventive treatment (TPT) in persons with HIV infection and HIV-negative household contacts* of pulmonary TB patients |
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Trial Objective |
To compare treatment success (adherence and completion of treatment) and safety of 1HP to 3HP in adolescents and adults who are living with HIV or are HIV-negative household contacts of an adult with confirmed pulmonary TB |
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Trial Design |
A multicenter, randomized, stratified, open label, phase IV trial among HIV-positive persons (PLHIV) on ART, or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary TB, who do not have evidence of active TB |
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Trial Sites |
South Africa: The Aurum Institute, Klerksdorp Clinical Research Site will only enrol HIV-positive persons. Mozambique: The Carmelo Hospital in Chokwe, Mozambique will only enrol HIV-negative household contacts of adults with confirmed pulmonary TB. India: The Byramjee Jeejeebhoy Government Medical College (BJGMC)-JHU Clinical Research Site (CRS) in Pune, India will only enrol HIV-positive persons. Indonesia: The Research Institute in Jakarta, University of Indonesia, Indonesia will only enrol HIV-negative household contacts of adults with confirmed pulmonary TB. |
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Outcome |
Trial approval pending |
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Protocol Title |
Phase I/II Dose Finding and Safety Study of Rifapentine and Isoniazid in HIV-Infected and HIV-Uninfected Children With Latent Tuberculosis Infection |
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Treatment Indication |
Rifapentine (given as water-dispersible monolayer and/or fixed dose combination with isoniazid) dosing in HIV-infected and uninfected children ≤ 12 years of age with latent TB infection (LTBI) or with exposure to Mycobacterium tuberculosis |
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Trial Objective |
Rifapentine exposure among participants by median area under the curve (AUC) [Time Frame: 12 weeks] Target AUC is no more than 25% lower than, and no more than 75% higher than, the target AUC of 522 mcg*h/L. Data to be used for dose adjustments throughout the study and to create dosing algorithm for paediatric subgroups. |
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Trial Design |
Phase I/II Dose Finding and Safety Study of Rifapentine and Isoniazid in HIV-Infected and HIV-Uninfected Children With Latent Tuberculosis Infection |
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Trial Sites |
South Africa, in Johannesburg and Cape Town, at a minimum of three clinical research sites. |
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Outcome |
Trial approval pending. |
