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 measure
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 (if study stopped)
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 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17503747
Publication citations
-
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.