Condition category
Infections and Infestations
Date applied
03/10/2000
Date assigned
03/10/2000
Last edited
29/09/2009
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

Dr Malcolm Hooker

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9719167 (extension, ProCom trial)

Study information

Scientific title

Acronym

The FORTE trial

Study hypothesis

To evaluate, in patients starting anti-HIV therapy, the activity over at least 48 weeks of two regimens in terms of effects on plasma HIV RNA, CD4 cell counts, viral resistance, progression of HIV disease and survival, and safety and tolerability.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

HIV, Acquired Immunodeficiency Syndrome (AIDS)

Intervention

1. Didanosine (ddI), Stavudine (d4T), Nevirapine (NVP) plus Nelfinavir (NFV) for at least 24 weeks, then ddI, d4T and NVP as maintenance therapy
2. Continuous ddI, d4T plus NVP

Note: third arm with continuous ddI, d4T, NVP plus NFV deleted November 2000.

Intervention type

Drug

Phase

Not Specified

Drug names

2 regimens

Primary outcome measures

Virological failure defined as failure to achieve plasma HIV RNA less than 50 copies per millilitre during the first 24 weeks or, having achieved such a level of suppression, subsequent rebound of plasma HIV RNA above 400 copies per millilitre.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1999

Overall trial end date

01/07/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years or more with documented HIV-1 infection and requiring anti-retroviral therapy
2. CD4 count greater than 25 x 10 to the power of 6 per litre
3. Any stage of HIV disease including recent infection (except acute symptomatic primary infection)
4. Likely to survive at least 2 years and take the allocated therapy for at least 6 months
5. Able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

1. Previous anti-retroviral treatment or immunotherapies
2. Peripheral nephropathy or a history of pancreatitis
3. Women who are pregnant, breastfeeding or not taking adequate contraception
4. Heterosexual men not willing to use barrier contraception
5. Receiving combination chemotherapy for cancer
6. Receiving parenteral therapy for an opportunistic infection
7. Unlikely to comply with the protocol
8. At screening with creatinine above upper limit of normal (ULN), ALT or AST above 2.5 times ULN, amylase above 1.5 times ULN (except if pancreatic amylase less than 1.5 times ULN), haemoglobin less than 10.5g/dl, neutrophils less than 1.0 or platelets less than 100

Recruitment start date

01/10/1999

Recruitment end date

01/07/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17503747

Publication citations

  1. Results

    Asboe D, Williams IG, Goodall RL, Darbyshire JH, Hooker MH, Babiker AG, , A virological benefit from an induction/maintenance strategy: the Forte trial., Antivir. Ther. (Lond.), 2007, 12, 1, 47-54.

Additional files

Editorial Notes