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
Protocol serial number	G9719167 (extension, ProCom trial)
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Malcolm Hooker
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	The FORTE trial
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	2 regimens
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/07/2002

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	01/10/1999
Date of final enrolment	01/07/2002

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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