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

Completed

• Conditions: Infections and Infestations; Human immunodeficiency virus (HIV); HIV, Acquired Immunodeficiency Syndrome (AIDS)

• Registration Number: ISRCTN57857428
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-10-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 307

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration