Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
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
Overall study end date
30/06/2000
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Other
Sex
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, England, United Kingdom
Study 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 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2002 | Yes | No |