Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463086
Status:
COMPLETED
Last Update Posted:
2012-07-17
First Post:
2007-04-19
Brief Title:
Isoniazid Plus Antiretroviral Therapy to Prevent Tuberculosis in HIV-infected Persons
Sponsor:
University of Cape Town
Organization:
University of Cape Town
Study Overview
Official Title:
A Randomized-controlled Trial of Isoniazid Plus Highly Active Antiretroviral Therapy Against Placebo to Prevent Tuberculosis in HIV-infected Persons
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HAART-IPT
Brief Summary:
The purpose of this study is to evaluate whether isoniazid can safely and further reduce the risk of tuberculosis in HIV infected people receiving HAART
Detailed Description:
The incidence of Tuberculosis TB in poor settlements around Cape Town continues to rise despite highly-active-anti-retroviral therapy HAART roll-out and DOTS In Khayelitsha district where this project will be conducted TB incidence is about 1600100000 There is an equally high HIV prevalence currently 33 Over 50 of adults presenting with active TB are co-infected with HIV and a third of all patients starting HAART have active TB Although HAART has been shown to reduce the overall risk of TB by 59-80 this risk still far exceeds the general risk In the Khayelitsha HAART cohort the risk of developing TB whilst on HAART is 12 per 100 p-y In the nearby community of Gugulethu there is a 14 risk of active TB with at least half of the cases occurring within the first 3months on HAART In a region where RD1-detected prevalence of latent TB infection is at least 80 there is a real concern that TB will likely undo the benefit of HAART in the long run Additional measures are therefore required to reduce the risk of TB in those already receiving or starting HAART Isoniazid preventive therapy IPT represents an option but there is insufficient evidence to determine whether IPT can further and safely reduce the risk of TB in the HAART era In a RCT we propose to evaluate whether IPT can reduce the risk of active TB in patients receiving HAART
A total minimum sample size of 1204 is required for the study to detect a 35 reduction in the hazard rates for tuberculosis in the intervention group h1 0052 compared to the control group h00085 at a power of 80 and a Type II error of 005 Our maximum targeted sample size when losses to follow-up and subgroup analyses are considered is 1445 Development of TB will be the primary endpoint
Additional information on 10 August 2010
Recruitment and enrolment into the study was completed in October 2009 We have screened over 2000 patients already on ART and those newly starting ART However instead of enrolling our desired maximum sample size of 1445 a revised minimum total of 1368 were instead randomized to the study drug This followed an amendment to the sample size necessitated by new information on the clinical site primarily higher rates of patients lost to follow-up at the clinical site than previously anticipated The amendment to our sample size was reported to and acknowledged by the Research Ethics Committee of the University of Cape Town Follow-up of participants will continue until OctNovember 2011
A total minimum sample size of 1204 is required for the study to detect a 35 reduction in the hazard rates for tuberculosis in the intervention group h1 0052 compared to the control group h00085 at a power of 80 and a Type II error of 005 Our maximum targeted sample size when losses to follow-up and subgroup analyses are considered is 1445 Development of TB will be the primary endpoint
Additional information on 10 August 2010
Recruitment and enrolment into the study was completed in October 2009 We have screened over 2000 patients already on ART and those newly starting ART However instead of enrolling our desired maximum sample size of 1445 a revised minimum total of 1368 were instead randomized to the study drug This followed an amendment to the sample size necessitated by new information on the clinical site primarily higher rates of patients lost to follow-up at the clinical site than previously anticipated The amendment to our sample size was reported to and acknowledged by the Research Ethics Committee of the University of Cape Town Follow-up of participants will continue until OctNovember 2011
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None