Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201110000301425 Date of Registration: 06/06/2011
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prevention of early mortality by presumptive TB treatment [retrospectively registered]
Official scientific title Prevention of early mortality by presumptive TB treatment in HIVinfected
Brief summary describing the background and objectives of the trial Despite the large-scale roll out of antiretroviral treatment (ART) which has great benefit long-term, there is substantial mortality of HIV-infected patients waiting for ART initiation and during the first months of treatment. With this project we aim to improve early survival of patients on ART by early and presumptive treatment of tuberculosis (TB).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PROMPT
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Tuberculosis
Purpose of the trial Prevention
Anticipated trial start date 01/07/2011
Actual trial start date 20/10/2011
Anticipated date of last follow up 31/12/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 334
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified block randomization Central electronic randomization Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ART only ART according to national standards Indeterminate 167
Experimental Group TB medication + ART Standard intense/continued TB regimen 24 weeks TB / ART indeterminate Presumptive TB meds with ART within 2 wks after start TB med 167
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
At least 18 years of age. HIV-1 infected as documented and confirmed by a licensed rapid test for HIV-1 antibodies or HIV-1 antibody ELISA. Eligible for antiretroviral treatment with CD4 T cell count<50 cells/µl. BMI <18 kg/m2 Ability to understand and provide written informed consent for the study. Patient has smear-positive pulmonary TB. Fulfills the diagnostic criteria for smear-negative pulmonary or extrapulmonary TB. Previous TB treatment (history of TB medication for >1 month. History of using antiretroviral drugs (except short course pMTCT). Symptomatic known underlying liver disease or transaminases >5x upper limit of normal. Known or suspected drug resistance to more than one first-line TB drug (e.g. household contacts of MDR-TB patients). Pregnant or breast-feeding. Cryptococcal meningitis (CrAG positive with neurologic symptoms). Creatinine clearance <=50 ml/minute Other severe (opportunistic) disease such as disseminated KS, malignant lymphoma, toxoplasmosis who may not be able to tolerate anti-TB medication or require other specific therapy. Unresolved danger signs (respiratory rate>30 per minute, heart rate>120bpm, temperature>39oC, unable to ambulate)(requiring empiric antibiotics). Taking other potentially life-saving medications (e.g. for other OIs, or immunosuppressants) that are incompatible with anti-TB chemotherapy or ART. Unable to swallow TB medications. Unable to follow-up at the clinic for regularly scheduled visits (e.g. too far from clinic). 18 Year(s) 110 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/06/2011 UNCST
Ethics Committee Address
Street address City Postal code Country
Kampala Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/08/2011 National IRB
Ethics Committee Address
Street address City Postal code Country
Gabon
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/08/2011 National IRB
Ethics Committee Address
Street address City Postal code Country
Mozambique
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/06/2011 UNCST
Ethics Committee Address
Street address City Postal code Country
Kampala Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/08/2011 National IRB
Ethics Committee Address
Street address City Postal code Country
Gabon
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/08/2011 National IRB
Ethics Committee Address
Street address City Postal code Country
Mozambique
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 16/09/2011 MCC
Ethics Committee Address
Street address City Postal code Country
South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ All-cause mortality in the first 24 weeks after initiation of ART Survival analysis Censoring of data at lost to follow-up (date of last visit), end of follow-up (6 months after start ART)
Secondary Outcome Pulmonary TB (based on available clinical and laboratory information including smear examination, culture, chest X-ray, and clinical assessment) Pulmonary TB in the first 24 weeks after initiation of ART
Secondary Outcome unmasking TB Survival analysis Censoring of data at lost to follow-up (date of last visit), death (date of death), end of follow-up (6 months after start ART)
Secondary Outcome sensitivity and specificity of clinical predictors (symptoms, signs, laboratory parameters) for incident unmasking TB 24 weeks after initiation of ART
Secondary Outcome causes of death Study duration
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Catholique University of Mozambique Beira Mozambique
Albert Schweitzer Hospital Lambarene Gabon
Infectious Diseases Institute University Makerere Mulago Hill Kampala Uganda
University of Limpopo Medunsa Campus Pretoria South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Academic Medical Center, University of Amsterdam Meibergdreef 9 Amsterdam 1105AZ Netherlands University
COLLABORATORS
Name Street address City Postal code Country
M Frank Wilkelmstrasse 27 Tübingen D-72074 Germany
Yukari Manabe 2190 Kampala Place, Kampala Uganda
Robert Colenbunders Nationalestraat 155, Antwerp Belgium
Olga Mogiyana Mzileni MEDUNSA GARANKUWA Pretoria 0204 South Africa
J Ferro Rua Marques de Soveral, 960 Beira 821 Mozambique
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yuka Manabe ymanabe@idi.co.ug +256753537198 Mulago Hill
City Postal code Country Position/Affiliation
Kampala Uganda Head of Research
Role Name Email Phone Street address
Public Enquiries Frank Cobelens f.cobelens@aighd.org +31205667800 Pietersbergweg 9
City Postal code Country Position/Affiliation
Amsterdam 1105BM Netherlands Professor of International Health
Role Name Email Phone Street address
Scientific Enquiries Frank Cobelens f.cobelens@aighd.org +31205667800 Pietersbergweg 9
City Postal code Country Position/Affiliation
Amsterdam 1105BM Netherlands Professor of International Health
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information