HIV, Acquired Immunodeficiency Syndrome (AIDS) Infections and Infestations Human immunodeficiency virus (HIV)
Conditions
Interventions
Adefovir dipivoxil/placebo
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are: changes in plasma HIV RNA by 8 and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Australia, United Kingdom
Outcome results
None listed