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 |
| Secondary identifying numbers | N/A |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Highly Active Antiretroviral Treatment (HAART) |
| Primary outcome measure | 1. WHO clinical stage, assessed after one and possibly also after two years of treatment 2. Changes in CD4 count after randomisation and after start of treatment |
| Secondary outcome measures | 1. Weight maintenanace 2. Intercurrent diseases 3. Acquired Immune Deficiency Syndrome (AIDS) development 4. Survival |
| Overall study start date | 01/07/2007 |
| Overall study end date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/07/2007 |
| Recruitment end date | 31/12/2010 |
Locations
Countries of recruitment
- Cameroon
- Norway
Study participating centre
University of Tromsø
Tromsoe
9012
Norway
9012
Norway
Sponsor information
Institute of Community Medicine, University of Tromsø (Norway)
University/education
University/education
Breivika
-
9037
Norway
| Phone | +47 77644000 |
|---|---|
| anne.fismen@ism.uit.no | |
| Website | http://uit.no/samfmed/ |
"ROR" |
https://ror.org/00wge5k78 |
Funders
Funder type
University/education
Institute of Community Medicine, University of Tromso (Norway)
No information available
Norwegian Global Health Program (Norway)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
