Contact information
Type
Scientific
Contact name
Dr Philip Onyebujoh
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 4478
onyebujohp@who.int
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
South Africa (A50560), Zambia (A50636), Uganda (A30224) and Tanzania (A30213)
Study information
Scientific title
Acronym
TB-HAART
Study hypothesis
That early concomitant treatment with TB and HIV medications may improve TB outcomes and improve survival.
As of 12/07/2011 the anticipated end date for this trial has been updated from 30/05/2009 to 30/06/2014.
Ethics approval(s)
Ethics approval received on the 17/08/2005.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) co-infections
Intervention
Placebo controlled trial.
Patients with TB-HIV co-infection with CD4 counts above 220, to be randomised into combined treatment with anti-TB and HIV medications and then HAART after six months, or anti-TB plus placebo for six months and then HAART thereafter.
All patients will be on HAART after six months, and post-trial medication is provided by the governments of participating countries.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Highly Active Anti-Retroviral Therapy (HAART)
Primary outcome measure
The proportion of subjects reaching the composite endpoint of treatment failure or death at six months after the initiation of short-course chemotherapy for TB.
Secondary outcome measures
1. The proportion of patients with TB relapse in the 24 months after initiation of short course chemotherapy in the two treatment groups
2. The proportion of patients reaching the multiple endpoint of treatment failure, relapse or death evaluated at 24 months after TB treatment initiation
3. The safety and tolerability of HAART used concomitantly with anti-TB medication
Overall study start date
30/05/2006
Overall study end date
30/06/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 to 65 years
2. HIV treatment naive patients (established by history)
3. CD 4 T-cell count between 220-500 cells/l
4. No history of previous anti-TB chemotherapy
5. A traceable home address and contact details to facilitate home visits with a firm commitment to remain traceable and to be able to access a defined treatment/service point for 24 months
6. Not enrolled in any other drug or treatment trials
7. Informed consent for HIV testing (since the study population will be smear positive TB patients co-infected with HIV)
8. Informed consent to participate in the trial
9. For female subjects, the following conditions are to be met:
9.1. Has been post-menopausal for at least one year, or
9.2. Is surgically incapable of bearing children, or
9.3. Is of childbearing potential and all of the following conditions are met:
9.3.1. Had a normal menstrual flow within one month before study entry
9.3.2. Has a negative pregnancy test (urine) immediately before study entry (and later confirmed by serum pregnancy test)
9.3.3. Must agree to use an accepted method of contraception (i.e. barrier methods or intrauterine device [IUD]). The subject must agree to continue with the same method throughout the study
Note: If a patient is using a long-acting hormonal contraceptive (such as Depot-Provera), the patient can be enrolled in the study, however she should be advised to use it in conjunction with a barrier method or IUD due to the known pharmacokinetic interaction between the various study medications and hormonal contraceptives. If an oral hormonal agent is in use, the patient should be advised to change the method of contraception in favour of barrier methods.
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
1900
Participant exclusion criteria
1. Evidence (laboratory and clinical history) of pre-existing non-tuberculosis disease likely to affect the response to, or assessment of treatment effects or represent contraindications to the study medication:
1.1. Diabetes mellitus
1.2. Liver impairment (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] greater than 2 x the upper limit of normal value)
1.3. Renal failure (serum creatinine greater than 2.0 mg/dl)
1.4. Epilepsy
1.5. Optical neuritis
1.6. Pancreatitis (lipase greater than 140 U/l)
1.7. Neutropenia (total neutrophil count less than 1200 cells/l)
1.8. Severe anaemia (haemoglobin less than 6.9 g/dl)
1.9. Any other condition that in the view of the country Principal Investigator represents a contraindication to the study medication
2. Mental illness (clinical suspicion of schizophrenia, manic-depressive illness, dementia)
3. Stage IV disease (according to World Health Organization [WHO] staging system)
4. Weight below 30 kg
5. Moribund or clinical evidence of severe illness
Recruitment start date
30/05/2006
Recruitment end date
30/06/2014
Locations
Countries of recruitment
South Africa, Switzerland, Tanzania, Uganda, Zambia
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
World Health Organization (WHO) (Switzerland)
Sponsor details
20 Avenue Appia
Geneva 27
CH-1211
Switzerland
+41 (0)22 791 4478
onyebujohp@who.int
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO) (Switzerland)
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
Switzerland
Funder name
US Agency for International Development (USAID) (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
GlaxoSmithKline (GSK) - drug supply
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Merck & Co Inc. - drug supply
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2014 | Yes | No |