An open randomised trial to evaluate the activity and tolerability of combinations of reverse transcriptase and protease inhibitors, including induction therapy, in individuals with Human Immunodeficiency Virus-1 (HIV-1) infection and CD4 cell counts greater than 25 x 10 to the power of 6 per litre

ISRCTN ISRCTN58987964
DOI https://doi.org/10.1186/ISRCTN58987964
Secondary identifying numbers G9719167 (extension, ProCom trial)
Submission date
03/10/2000
Registration date
03/10/2000
Last edited
29/09/2009
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

Dr Malcolm Hooker
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymThe FORTE trial
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHIV, Acquired Immunodeficiency Syndrome (AIDS)
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)2 regimens
Primary outcome measureVirological 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 measuresNot provided at time of registration
Overall study start date01/10/1999
Completion date01/07/2002

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants100
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/10/1999
Date of final enrolment01/07/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2007 Yes No