Completed

Cidofovir (HPMPC) for Peripheral Cytomegalovirus Retinitis in AIDS Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Cidofovir

+ Probenecid

Drug
Who is being recruted

Blood-Borne Infections+22

+ Urogenital Diseases

+ Genital Diseases

From 13 to 60 Years
+36 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorGilead Sciences
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Patients are randomized to one of two treatment arms. Group A receives HPMPC by IV infusion weekly for 2 consecutive weeks (induction) and then every other week (maintenance) with oral probenecid and IV hydration. Group B receives no treatment until the time of retinitis progression (deferred treatment), at which time they receive the same regimen as Group A, provided retinitis progression is not immediately sight-threatening.

NCT00002437
Principal SponsorGilead Sciences
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 13 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesDNA Virus InfectionsEye DiseasesHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetinal DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralEye InfectionsEye Infections, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsRetinitisHIV InfectionsCytomegalovirus Retinitis

Criteria

15 inclusion criteria required to participate
Allowed: Oral trimethoprim/sulfamethoxazole.
Diagnosis of peripheral (not immediately sight-threatening) CMV retinitis.
Allowed: Antiretroviral agents.
Life expectancy of at least 3 months.
Show More Criteria
21 exclusion criteria prevent from participating
Excluded: Other investigational drugs with potential nephrotoxicity.
Excluded: Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin as therapy for CMV disease (although permitted if previously received solely as prophylaxis).
Excluded: Intravenous pentamidine.
Media opacity that precludes visualization of the fundus of both eyes.
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Los Angeles County - USC Med Ctr

Los Angeles, United StatesOpen Los Angeles County - USC Med Ctr in Google Maps

UCI Med Ctr

Orange, United States

Mount Zion Med Ctr

San Francisco, United States

Beth Israel Hosp

Boston, United States
Completed9 Study Centers