A Study of Cidofovir in HIV-Infected Children With Cytomegalovirus (CMV) Disease
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Part A: To determine the safety and pharmacokinetics of sequential single doses of cidofovir
in HIV-infected children with end-organ cytomegalovirus (CMV) disease. Part B: To determine
the safety (including time to progression of CMV retinitis by retinal exam),
pharmacokinetics, and long-term (6 months) tolerance of multiple-dose cidofovir in
HIV-infected children with CMV retinitis. Part B: To determine the effect of multiple-dose
cidofovir on the virologic parameters of CMV retinitis (viral load, shedding, and resistance
to antiviral agents).
[AS PER AMENDMENT 1/7/98: To determine the safety, tolerance and pharmacokinetics of
sequential single doses of cidofovir in HIV-infected children with CMV retinitis. To
determine the safety (including time to progression of CMV retinitis by retinal exam),
pharmacokinetics, and long-term (6-month) tolerance of multiple doses of cidofovir in
HIV-infected children with CMV retinitis.] While the intravenous formulation of cidofovir has
been approved for the treatment of CMV retinitis in HIV-infected individuals, information is
limited regarding its safety and tolerance in HIV-infected children. Intravenous cidofovir
requires less frequent administration for both induction and maintenance therapy of CMV
retinitis than other currently available therapies. If found to be safe and well tolerated in
HIV-infected children with CMV retinitis, intravenous cidofovir would add significantly to
agents available to treat this debilitating opportunistic infection.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)