Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Cytomegalovirus (CMV) infection is a common opportunistic infection (OI) in HIV patients. The purpose of this study is to find out whether valganciclovir, an antiviral approved by the FDA for the treatment of CMV in the eye, is safe and effective in preventing CMV organ damage in people with HIV.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Ganciclovir; Valganciclovir

Criteria

Note: Per a recommendation from NIAID Therapeutic Trials Data Safety Monitoring Board (DSMB), this trial will close on 10/03/05. The DSMB has determined that the study will reach the primary objective. All participants not on valganciclovir must complete all study evaluations by 08/31/05; all participants taking valganciclovir must complete study evaluations by 10/03/05.

Inclusion Criteria for Step 1:

• HIV infected

• Viral load greater than 400 copies/ml

• CD4 count less than 100 cells/mm3

• Have taken HAART for 3 months or longer OR are not taking HAART and do not plan to start HAART for at least 3 months after study entry

• Have serum CMV IgG antibodies

• Have consent of parent or guardian if under 18 years of age

• Willing to use acceptable forms of contraception

Exclusion Criteria for Step 1:

• History of CMV end-organ disease

• Certain antiviral drugs for CMV prophylaxis within 8 weeks of study entry

• Pregnant or breastfeeding

• Currently require ongoing foscarnet or cidofovir. Limited courses of foscarnet or cidofovir for the treatment of diseases other than CMV are permitted if approved by the protocol chairs.