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ISRCTN
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ISRCTN31541725
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DOI
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10.1186/ISRCTN31541725
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised phase II trial to compare the toxicity, tolerability and activity of 2-drug combinations of the nucleoside analogue reverse transcriptase inhibitors (NRTIs) lamivudine ((-)2'-deoxy-3'thiacytidine, 3tc), zidovudine (ZDV) and 1592U89
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Scientific title
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Acronym
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PENTA 5
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Serial number at source
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G9627716
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Study hypothesis
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Primary:
1. To compare the toxicity, tolerability and activity of three different 2-drug NRTI combinations in children taking either NFV or NFV placebo in Part A, and in those taking NFV in Part B. Activity will be assessed by effect on viral load measured by plasma HIV-1 RNA
2. To assess the tolerability and toxicity of NFV and NFV placebo in children in Part A
Secondary:
1. To compare the activity of NFV and NFV placebo in children taking one of the three 2-drug combinations in Part A
2. To describe the effect on viral resistance, CD4 cell count and clinical progression separately for the three NRTI groups and the NFV and NFV placebo groups
3. To compare the plasma viral load as measured by HIV-1 RNA in the 1592-containing arms with that in the non-1592 arms in children taking NFV or NFV placebo
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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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Europe
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Disease/condition/study domain
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Human Immunodeficiency Virus (HIV), Acquired Immunodeficiency Syndrome (AIDS)
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Participants - inclusion criteria
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1. 3 months to 16 years of age
2. Definitive HIV-1 infection
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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23/01/1998
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Anticipated end date
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31/07/1999
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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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120
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Interventions
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Three different 2-drug nucleoside analogue reverse transcriptase inhibitors (NRTI) combinations in children taking either nelfinavir (NFV) or nelfinavir (NFV) placebo
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Primary outcome measure(s)
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1. To compare the combination of two NRTIs plus a protease inhibitor (PI) versus two NRTIs plus a non-nucleoside reverse transcriptase inhibitor (NNRTI) as initial therapy, followed by second-line therapy if virologic failure occurs, in terms of their effects on a long-term virologic endpoint
2. To compare two different viral load criteria for switching from first-line to second-line therapy
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Secondary outcome measure(s)
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1. To evaluate and compare the safety and tolerability of each drug combination (including first- and second-line therapies)
2. To compare the long-term clinical and immunologic outcomes (by the initial randomization)
3. To compare the proportions of children who have undergone one regimen switch or reached study end-point (by the initial randomization)
4. To compare time from randomization to virologic failure (RNA >400 copies/ml at or after week 24) of the first-line therapy analyzed by initial randomization to either protease inhibitor (PI) or NNRTI containing regimens
5. To compare time from randomization to virologic failure of the second line therapy (RNA >30,000 copies/ml) analyzed by the initial randomization
6. To compare the proportion of children with plasma HIV-1 RNA <400 copies/ml at 4 years (by the initial randomization)
7. To describe resistance patterns at 4 years (by the initial randomization)
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Sources of funding
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Medical Research Council (UK)
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Trial website
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http://www.pentatrials.org/trials.htm#penpact1
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Publications
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Results:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11531953
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10776748
3. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12134227
4. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12351958
5. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12544410
6. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17457088
7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11888583
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Contact name
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Prof
Diana
Gibb
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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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Tel
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+44 (0)20 7670 4709
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Fax
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+44 (0)20 7670 4818
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Email
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d.gibb@ctu.mrc.ac.uk
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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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03/03/2008
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Date ISRCTN assigned
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03/10/2000
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