HIV Clinical Trial
— WHIP3TBOfficial title:
A Randomised, Pragmatic, Open-Label Trial To Evaluate The Effect Of Three Months Of High Dose Rifapentine Plus Isoniazid Administered As A Single Round Or Given Annually In HIV-Positive Individuals
Verified date | October 2019 |
Source | The Aurum Institute NPC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a parallel, two part, open label, individually randomized, pragmatic trial among HIV-positive individuals. Part A compares a single round of weekly high dose rifapentine plus isoniazid for three months (3HP) to six months of daily isoniazid (6H). Part B compares periodic 3HP (p3HP) to a single round of 3HP.
Status | Completed |
Enrollment | 4027 |
Est. completion date | October 18, 2019 |
Est. primary completion date | October 18, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years and older |
Eligibility |
Inclusion Criteria: - At least two years of age - Known HIV infection - Antiretroviral therapy (ART) ineligible or on ART for =3 months Exclusion Criteria: - 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 - Suspected acute hepatitis or known chronic liver disease - ALT/AST >5 times the upper limit of normal (regardless of symptoms of hepatitis) - 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 |
Country | Name | City | State |
---|---|---|---|
South Africa | The Aurum Institute NPC | Johannesburg | Gauteng |
Lead Sponsor | Collaborator |
---|---|
The Aurum Institute NPC | Aurum Institute, Johns Hopkins University, London School of Hygiene and Tropical Medicine |
South Africa,
Martinson NA, Barnes GL, Moulton LH, Msandiwa R, Hausler H, Ram M, McIntyre JA, Gray GE, Chaisson RE. New regimens to prevent tuberculosis in adults with HIV infection. N Engl J Med. 2011 Jul 7;365(1):11-20. doi: 10.1056/NEJMoa1005136. — View Citation
Sterling TR, Benson CA, Shang N. Tolerability among HIV-infected persons of three months of once-weekly rifapentine + INH (3HP) vs. 9 months of daily INH (9H) for treatment of latent tuberculosis infection. In: International AIDS Society Conference. Washington, DC.; 2012.
Sterling TR, Moro RN, Borisov AS, Phillips E, Shepherd G, Adkinson NF, Weis S, Ho C, Villarino ME; Tuberculosis Trials Consortium. Flu-like and Other Systemic Drug Reactions Among Persons Receiving Weekly Rifapentine Plus Isoniazid or Daily Isoniazid for Treatment of Latent Tuberculosis Infection in the PREVENT Tuberculosis Study. Clin Infect Dis. 2015 Aug 15;61(4):527-35. doi: 10.1093/cid/civ323. Epub 2015 Apr 22. — View Citation
Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven-Sizemore E, Hackman J, Hamilton CD, Menzies D, Kerrigan A, Weis SE, Weiner M, Wing D, Conde MB, Bozeman L, Horsburgh CR Jr, Chaisson RE; TB Trials Consortium PREVENT TB Study Team. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011 Dec 8;365(23):2155-66. doi: 10.1056/NEJMoa1104875. — View Citation
Villarino ME, Scott NA, Weis SE, Weiner M, Conde MB, Jones B, Nachman S, Oliveira R, Moro RN, Shang N, Goldberg SV, Sterling TR; International Maternal Pediatric and Adolescents AIDS Clinical Trials Group; Tuberculosis Trials Consortium. Treatment for preventing tuberculosis in children and adolescents: a randomized clinical trial of a 3-month, 12-dose regimen of a combination of rifapentine and isoniazid. JAMA Pediatr. 2015 Mar;169(3):247-55. doi: 10.1001/jamapediatrics.2014.3158. Erratum in: JAMA Pediatr. 2015 Sep;169(9):878. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | IGRA conversions (part A) | Number of IGRA-negative participants without evidence of active TB at enrollment with the occurrence of IGRA conversions at the end of year 1 | 1 year | |
Other | IGRA reversions (part A) | Number of IGRA-positive participants without evidence of active TB at enrollment with the occurrence of IGRA reversions at the end of year 1 | 1 year | |
Other | Incidence of TB resistant to isoniazid and/or rifapentine | Number of individuals without evidence of active TB at enrollment who are diagnosed with active TB resistant to isoniazid and/or rifapentine | 2 years | |
Primary | Treatment completion (part A) | Number of participants without evidence of active TB at enrollment who complete treatment, defined as: Proportion of participants in 3HP group self-reporting treatment completion of =11 doses in a 16-week period ; Proportion or participants in 6H group self-reporting treatment completion of =167 doses over an 34 week (8-month) period |
1 year | |
Primary | TB incidence (part B) | Number of participants without evidence of active TB at enrollment who are diagnosed with active TB meeting the definition: Confirmed tuberculosis: Culture-positive, Xpert MTB/RIF-positive, or smear-positive for M. tuberculosis from any site in adults and children OR Clinical tuberculosis: Started on treatment for TB in adults and children | 2 years | |
Secondary | TB incidence (part A) | Number of participants without evidence of active TB at enrollment who are diagnosed with active TB meeting the definition: Confirmed tuberculosis: Culture-positive, Xpert MTB/RIF-positive, or smear-positive for M. tuberculosis from any site in adults and children OR Clinical tuberculosis: Started on treatment for TB in adults and children | 1 year | |
Secondary | All-cause mortality (part A) | Number of participants without evidence of active TB at enrollment who die from any cause | 1 year | |
Secondary | Permanent discontinuation of therapy due to treatment-related adverse events (part A) | Number of participants without evidence of active TB at enrollment who permanently discontinue therapy due to an adverse drug reaction | 1 year | |
Secondary | TB incidence (part B) | Number of participants without evidence of active TB during enrollment who are diagnosed with active TB meeting during the second year of follow-up. The definition of active TB is: Confirmed tuberculosis: Culture-positive, Xpert MTB/RIF-positive, or smear-positive for M. tuberculosis from any site in adults and children OR Clinical tuberculosis: Started on treatment for TB in adults and children | 1 year | |
Secondary | Treatment completion (part B) | Number of participants without evidence of active TB at enrollment who complete treatment, defined as: Proportion of participants in 3HP group self-reporting treatment completion of =11 doses in a 16-week period; Proportion or participants in p3HP group self-reporting treatment completion of =22 doses over two annual 16-week periods | 2 years | |
Secondary | All-cause mortality (part B) | Number of participants without evidence of active TB at enrollment who die from any cause | 2 years | |
Secondary | Permanent discontinuation of therapy due to treatment-related adverse events (part B) | Number of participants without evidence of active TB at enrollment who permanently discontinue therapy due to an adverse drug reaction | 2 years | |
Secondary | Cost per TB case prevented | Cost per TB case prevented | 2 years | |
Secondary | Cost per death averted | Cost per death averted | 2 years | |
Secondary | Cost per disability adjusted life year (DALY) averted by study arm | Cost per disability adjusted life year (DALY) averted by study arm | 2 years |
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