Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000894
First received: November 2, 1999
Last updated: February 22, 2011
Last verified: June 2003
  Purpose

To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV (cytomegalovirus) retinitis.

Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis.


Condition Intervention Phase
Cytomegalovirus Retinitis
HIV Infections
Drug: Cidofovir
Drug: Probenecid
Drug: Ganciclovir
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 300
Primary Completion Date: June 2000 (Final data collection date for primary outcome measure)
Detailed Description:

While cidofovir is effective in suppressing retinitis and prolonging time to progression, no studies have compared cidofovir to other therapies and its place in the treatment of CMV retinitis remains unexplored. By combining the ganciclovir intraocular device (slows retinitis progression) with oral ganciclovir (has the potential to treat both the ocular disease and to suppress dissemination to the contralateral eye and the viscera), without the use of a central venous catheter, this combination has become increasingly common. For these reasons, a comparative trial of cidofovir to other therapies is appropriate.

After being stratified by the clinic and by stage of disease, patients are randomized to 1 of 2 treatment arms: intravenous (IV) cidofovir (Group I) or intraocular ganciclovir device plus oral ganciclovir (Group II). Group I: Cidofovir is administered IV once weekly for 2 consecutive weeks, then every 2 weeks thereafter. If progression occurs, oral ganciclovir is added to treatment or if this regimen is not tolerated, patients are treated according to the best medical judgment. Concurrent oral probenecid and intravenous hydration are administered with each cidofovir infusion. Group II: An intraocular ganciclovir device is surgically implanted at baseline and then every 6 to 8 months and ganciclovir is administered orally. If more than 1 progression or unacceptable toxicity occurs, patients are treated according to the best medical judgment.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

You may be eligible for this study if you:

  • Are 13 years of age or older (parent or guardian consent required if under 18).
  • Agree to practice sexual abstinence or use effective birth control during and for 90 days after the study.
  • Have AIDS.
  • Have CMV retinitis.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have a history of heart or kidney disease.
  • Have medical problems which would prevent you from completing the study.
  • Are pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000894

Locations
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
United States, Florida
Univ of Miami / Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
United States, Georgia
Emory Eye Clinic
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern Univ / SOCA
Chicago, Illinois, United States, 60611
United States, Louisiana
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, New York
Cornell Univ Med Ctr
New York, New York, United States, 10021
New York Hosp / Cornell Med Ctr
New York, New York, United States, 10021
United States, North Carolina
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Texas
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
Sponsors and Collaborators
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00000894     History of Changes
Other Study ID Numbers: ACTG 350
Study First Received: November 2, 1999
Last Updated: February 22, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Infusions, Intravenous
Ganciclovir
Drug Therapy, Combination
Administration, Oral
Antiviral Agents
Drug Implants
Cytomegalovirus Retinitis
Eye
cidofovir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Ganciclovir
Cidofovir
Probenecid
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 22, 2014