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ISRCTN
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ISRCTN58987964
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DOI
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10.1186/ISRCTN58987964
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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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
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Scientific title
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Acronym
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The FORTE trial
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Serial number at source
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G9719167 (extension, ProCom trial)
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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HIV, Acquired Immunodeficiency Syndrome (AIDS)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/1999
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Anticipated end date
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01/07/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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100
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17503747
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Contact name
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Dr
Malcolm
Hooker
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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03/10/2000
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Last edited
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29/09/2009
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Date ISRCTN assigned
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03/10/2000
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