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ISRCTN
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ISRCTN57857428
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DOI
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10.1186/ISRCTN57857428
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Randomised placebo-controlled trial of adefovir dipivoxil in patients with Human immunodeficiency virus (HIV) infection
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Scientific title
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Acronym
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ADHOC
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Serial number at source
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G9719209
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Study hypothesis
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To assess the efficacy and safety of adefovir dipivoxil in patients with advanced HIV-1 infection.
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Lay summary
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Not provided at time of registration
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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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Australia, Europe
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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. HIV infection, aged 13 or more
2. Any stage of HIV disease except prior or currently active Cytomegalovirus (CMV) disease
3. Last CD4 count less than 100: 100-200 if ever less than 50 in the past
4. Can at least care for himself or herself
5. No changes to other anti-HIV drugs for the past 8 weeks
6. Are considered likely to survive for more than 3 months
7. Able to comply and give informed consent
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Participants - exclusion criteria
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1. Prior or current treatment with ganciclovir, forcamet, cidofovir and valacyclovir
2. Other anti-CMV drugs; interferons, immune modulators or CMV globulin within 30 days
3. Needing parenteral therapy for a serious infection
4. Receiving, or likely to receive, a course of systemic chemotherapy for cancer
5. Significant malabsorption, nausea or vomiting
6. Ocular opacities or retinopathy preventing the diagnosis of CMV retinitis
7. Pregnant, breastfeeding or pregnancy not excluded, or not taking adequate contraception if of childbearing potential
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Anticipated start date
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01/07/1997
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Anticipated end date
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30/06/2000
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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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307
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Interventions
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Adefovir dipivoxil/placebo
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Primary outcome measure(s)
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Primary endpoints are: changes in plasma HIV RNA by 8 and 24 weeks.
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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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2002 results on http://www.ncbi.nlm.nih.gov/pubmed/12444940
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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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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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11/08/2011
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Date ISRCTN assigned
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03/10/2000
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