Trials / Completed
CompletedNCT00002142
An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (planned)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and tolerance of cidofovir (HPMPC) infusions in AIDS patients with relapsing cytomegalovirus (CMV) retinitis. To determine the time to retinitis progression in this patient population. To evaluate the impact of cidofovir therapy on visual acuity.
Detailed description
Patients are randomized to receive intravenous HPMPC either at one dose for both induction and maintenance or at a higher dose for induction than for maintenance. Induction consists of two consecutive weekly doses followed by maintenance every other week. All patients receive concomitant probenecid and saline hydration. Treatment continues until retinitis progression, as assessed by retinal photographs, or treatment-limiting toxicity occurs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cidofovir | |
| DRUG | Probenecid |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00002142. Inclusion in this directory is not an endorsement.