Highly Active Antiretroviral Treatment (HAART) of Human Immunodeficiency Virus (HIV)-infection in a town in Cameroon: randomised controlled study to suggest which treatment starting point is most beneficial for the patients
| ISRCTN | ISRCTN22114173 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22114173 |
| Protocol serial number | N/A |
| Sponsor | Institute of Community Medicine, University of Tromsø (Norway) |
| Funders | Institute of Community Medicine, University of Tromso (Norway), Norwegian Global Health Program (Norway) |
- Submission date
- 29/06/2007
- Registration date
- 06/07/2007
- Last edited
- 03/08/2015
- 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
Prof Knut Holtedahl
Scientific
Scientific
Institute of Community Medicine
University of Tromsø
Tromsoe
9012
Norway
| Phone | +47 77644887 |
|---|---|
| knutarne.holtedahl@ism.uit.no |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Highly Active Antiretroviral Treatment (HAART) of Human Immunodeficiency Virus (HIV)-infection in a town in Cameroon: randomised controlled study to suggest which treatment starting point is most beneficial for the patients |
| Study acronym | CD4 RCT |
| Study objectives | Null hypothesis: no difference on outcome (corrected for lead bias) if treatment starts at CD4 levels 250 or 350 cells/mm^3 in World Health Organisation (WHO) clinical stage 1 - 2 patients. On 17/09/2008 the overall trial end date was changed from 31/12/2008 to 31/12/2010. |
| Ethics approval(s) | 1. Regional Medical Research Ethics Committee in Western Norway (REK VEST), 26/06/2002, ref: 115/02 2. In Cameroon: Oral approval from local health authorities |
| Health condition(s) or problem(s) studied | HIV infection |
| Intervention | Each participant will be randomised to one of the following groups: Group 1: HAART starting at CD4 levels 250 cells/mm^3 Group 2: HAART starting at CD4 levels 350 cells/mm^3 |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Highly Active Antiretroviral Treatment (HAART) |
| Primary outcome measure(s) |
1. WHO clinical stage, assessed after one and possibly also after two years of treatment |
| Key secondary outcome measure(s) |
1. Weight maintenanace |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Treatment naive Human Immunodeficiency Virus (HIV)-infected individuals 2. 16 years of age or older 3. CD4 count between 450 and 250 cells/mm^3 |
| Key exclusion criteria | 1. If patient fulfils current indications for immediate treatment: CD4 less than 250 cells/mm^3 or WHO clinical stage 3 or 4 2. If CD4 is currently greater than 450 cells/mm^3 . This is because patient will probably not start Anti-Retroviral Therapy (ART) during the first year to come |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Cameroon
- Norway
Study participating centre
University of Tromsø
Tromsoe
9012
Norway
9012
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/08/2014 | Yes | No |
