Randomised placebo-controlled trial of adefovir dipivoxil in patients with Human immunodeficiency virus (HIV) infection

ISRCTN	ISRCTN57857428
DOI	https://doi.org/10.1186/ISRCTN57857428
Secondary identifying numbers	G9719209

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	ADHOC
Study objectives	To assess the efficacy and safety of adefovir dipivoxil in patients with advanced HIV-1 infection.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	HIV, Acquired Immunodeficiency Syndrome (AIDS)
Intervention	Adefovir dipivoxil/placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Adefovir dipivoxil
Primary outcome measure	Primary endpoints are: changes in plasma HIV RNA by 8 and 24 weeks.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/1997
Completion date	30/06/2000

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	307
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/07/1997
Date of final enrolment	30/06/2000

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

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

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

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2002		Yes	No