Randomised placebo-controlled trial of adefovir dipivoxil in patients with Human immunodeficiency virus (HIV) infection
| ISRCTN | ISRCTN57857428 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57857428 |
| Protocol serial number | G9719209 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 03/10/2000
- Registration date
- 03/10/2000
- Last edited
- 14/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Malcolm Hooker
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Adefovir dipivoxil |
| Primary outcome measure(s) |
Primary endpoints are: changes in plasma HIV RNA by 8 and 24 weeks. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
- Australia
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2002 | Yes | No |
