Condition category
Infections and Infestations
Date applied
03/10/2000
Date assigned
03/10/2000
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Malcolm Hooker

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9719209

Study information

Scientific title

Acronym

ADHOC

Study hypothesis

To assess the efficacy and safety of adefovir dipivoxil in patients with advanced HIV-1 infection.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

HIV, Acquired Immunodeficiency Syndrome (AIDS)

Intervention

Adefovir dipivoxil/placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Adefovir dipivoxil

Primary outcome measures

Primary endpoints are: changes in plasma HIV RNA by 8 and 24 weeks.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/1997

Overall trial end date

30/06/2000

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

307

Participant 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

Recruitment start date

01/07/1997

Recruitment end date

30/06/2000

Locations

Countries of recruitment

Australia, United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2002 results in: http://www.ncbi.nlm.nih.gov/pubmed/12444940

Publication citations

  1. Results

    A randomized placebo-controlled trial of adefovir dipivoxil in advanced HIV infection: the ADHOC trial., HIV Med., 2002, 3, 4, 229-238.

Additional files

Editorial Notes