A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000688
First received: November 2, 1999
Last updated: March 11, 2011
Last verified: October 1990
  Purpose

To provide information about the usefulness and safety of giving injections of ganciclovir (DHPG) for treating peripheral cytomegalovirus (CMV) retinitis.

CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.


Condition Intervention Phase
Cytomegalovirus Retinitis
HIV Infections
Drug: Ganciclovir
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

Resource links provided by NLM:


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

Estimated Enrollment: 180
Primary Completion Date: February 1995 (Final data collection date for primary outcome measure)
Detailed Description:

CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.

Patients are randomly placed in one of two treatment groups. In one group, patients receive DHPG twice a day, intravenously, for 14 days, followed by a daily dose for 14 weeks. Patients in the other group (the delayed-treatment group) do not receive immediate treatment with DHPG. Patients in both groups have regular ophthalmologic (eye) evaluations with retinal photographs to see if the retinitis is getting worse. Patients in the delayed treatment group receive DHPG if this occurs.

  Eligibility

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

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Zidovudine (AZT) for patients in delayed treatment group and not receiving ganciclovir.
  • Didanosine (ddI) may be continued or initiated in any patient during the study.
  • Topical acyclovir.
  • Topical ophthalmics.
  • Aerosolized pentamidine.

Patients must have:

  • AIDS as defined by the CDC criteria or have had confirmation of HIV infection by ELISA, p24 antigen assay, or culture of HIV.
  • Retinal lesions greater than 1500 microns from edge of optic disc outside major temporal vascular arcades, and greater than 3000 microns from fovea.
  • Understanding of study provisions, and willingness to sign informed consent form approved by the appropriate Institutional Review Board and Syntex.
  • Life expectancy of at least 4 months.

Exclusion Criteria

Co-existing Condition:

Patients with ocular conditions requiring immediate surgical correction are excluded.

Concurrent Medication:

Excluded during first 4 weeks of ganciclovir treatment:

Zidovudine (AZT).

Excluded:

Other investigational drugs and antimetabolites, alkylating agents, nucleoside analogs (topical ophthalmics are permitted), acyclovir, interferon, foscarnet (non-nucleoside pyrophosphate analog), cytomegalovirus (CMV) hyperimmune globulin, and cytokines.

Patients with the following are excluded:

  • Immediately sight-threatening retinitis (= or < 1500 microns from edge of optic disc, or inside major temporal vascular arcades, or = or < 3000 microns from the fovea).
  • Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic and photographic retinal assessment.
  • Demonstrated hypersensitivity to acyclovir.

Prior Medication:

Excluded:

- Previous treatment with anti-cytomegalovirus therapy.

  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: NCT00000688

Locations
United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
Mount Zion Med Ctr
San Francisco, California, United States, 94115
Pacific Presbyterian
San Francisco, California, United States, 94118
Mills Hosp
San Mateo, California, United States, 94401
Stanford Univ School of Medicine
Stanford, California, United States, 94305
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
United States, Michigan
Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Kansas City Veterans Administration Med Ctr
Kansas City, Missouri, United States, 64128
Washington Univ Med Ctr
St Louis, Missouri, United States, 63110
United States, New Mexico
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, United States, 87131
United States, New York
Cornell Univ Med Ctr
New York, New York, United States, 10021
New York Univ Med Ctr / Dept of Environmental Med
New York, New York, United States, 10016
United States, Ohio
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, United States, 452670405
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
Plaza Med Ctr
Houston, Texas, United States, 77004
Infectious Diseases Association of Houston / Methodist Hosp
Houston, Texas, United States, 77030
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22203
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Spector SA
Study Chair: Jabs D
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00000688     History of Changes
Other Study ID Numbers: ACTG 071, RS-21592, ICM 1697
Study First Received: November 2, 1999
Last Updated: March 11, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Retinitis
Injections, Intravenous
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014