Condition category
Infections and Infestations
Date applied
29/06/2007
Date assigned
06/07/2007
Last edited
03/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Knut Holtedahl

ORCID ID

Contact details

Institute of Community Medicine
University of Tromsø
Tromsoe
9012
Norway
+47 77644887
knutarne.holtedahl@ism.uit.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Applicable

Drug names

Highly Active Antiretroviral Treatment (HAART)

Primary outcome measures

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 trial start date

01/07/2007

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

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

Trial participating centre

University of Tromsø
Tromsoe
9012
Norway

Sponsor information

Organisation

Institute of Community Medicine, University of Tromsø (Norway)

Sponsor details

Breivika
-
9037
Norway
+47 77644000
anne.fismen@ism.uit.no

Sponsor type

University/education

Website

http://uit.no/samfmed/

Funders

Funder type

University/education

Funder name

Institute of Community Medicine, University of Tromso (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Norwegian Global Health Program (Norway)

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25108448

Publication citations

Additional files

Editorial Notes