Status:
COMPLETED
Safety Tolerability DDI Short Course Treatment of LTBI Infection With High-dose Rifapentine and Isoniazid or Standard Isoniazid Preventive Therapy in HIV+ Patients (DOLPHIN & DOLPHIN TOO)
Lead Sponsor:
The Aurum Institute NPC
Collaborating Sponsors:
Johns Hopkins University
University of California
Conditions:
Respiratory Tract Infections
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Single-arm, single-center, Phase I/II clinical trial, in four groups. Individuals with HIV infection taking Efavirenz (EFV) and two nucleoside reverse transcriptase inhibitors (NRTI) who have undetect...
Detailed Description
Group 1 (n=30): The first 12 participants (Group 1A) will take dolutegravir 50 milligrams (mg) once daily (with tenofovir/emtricitabine) from Days 1-57. Semi-intensive PK sampling for dolutegravir wil...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Weight \> 50 kg
- Documented HIV infection\*
- At least 8 weeks of HIV treatment with efavirenz or dolutegravir plus two NRTI, or ART treatment naïve, depending upon the enrolling treatment Group
- Undetectable or detectable HIV-1 viral load, depending upon the enrolling treatment Group
Exclusion
- Confirmed or suspected TB disease
- Likely to move from the study area during the study period
- Known exposure to TB cases with known or suspected resistance to isoniazid or rifampicin in the source case
- TB treatment within the past year
- TB preventive therapy within the last year
- Sensitivity or intolerance to isoniazid or rifamycins
- On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens
- Suspected acute hepatitis or known chronic liver disease; severe hepatic impairment (Class C or greater) as determined by Child Pugh classification
- ALT≥ 3 times the upper limit of normal (ULN)
- Total bilirubin ≥ 2.5 times the ULN
- Absolute neutrophil count (ANC) ≤ 750 cells/mm3
- Creatinine clearance \< 50 ml/min
- Pregnancy or breastfeeding
- Women of childbearing potential who are unable or unwilling to use contraception
- Self-reported alcohol use exceeding 28 units per week for men, or 21 units for women
- Karnofsky status \< 80
- On prohibited medications e.g. dofetilide (see Appendix 1)
- Known porphyria
Key Trial Info
Start Date :
January 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2022
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT03435146
Start Date
January 18 2018
End Date
December 7 2022
Last Update
February 2 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Aurum Institute: Tembisa Clinical Research Centre
Tembisa, Gauteng, South Africa, 1736