An evaluation of the impact of early initiation of Highly Active Anti-Retroviral Therapy (HAART) on Tuberculosis (TB) treatment outcomes for TB patients co-infected with Human Immunodeficiency Virus (HIV)
| ISRCTN | ISRCTN77861053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77861053 |
| Protocol serial number | South Africa (A50560), Zambia (A50636), Uganda (A30224) and Tanzania (A30213) |
| Sponsor | World Health Organization (WHO) (Switzerland) |
| Funders | World Health Organization (WHO) (Switzerland), US Agency for International Development (USAID) (USA), GlaxoSmithKline (GSK) - drug supply, Merck & Co Inc. - drug supply |
- Submission date
- 29/03/2006
- Registration date
- 29/03/2006
- Last edited
- 30/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philip Onyebujoh
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 4478 |
|---|---|
| onyebujohp@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | TB-HAART |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Highly Active Anti-Retroviral Therapy (HAART) |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. The proportion of patients with TB relapse in the 24 months after initiation of short course chemotherapy in the two treatment groups |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1900 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 30/05/2006 |
| Date of final enrolment | 30/06/2014 |
Locations
Countries of recruitment
- South Africa
- Switzerland
- Tanzania
- Uganda
- Zambia
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2014 | Yes | No |
