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	Treatment or Intervention	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Ganciclovir	Phase III

Further Study Details: 

Expected Total Enrollment:  180

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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.

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

Study chairs or principal investigators

Spector SA,  Study Chair
Jabs D,  Study Chair

Study ID Numbers:  ACTG 071; RS-21592; ICM 1697
Record last reviewed:  October 1990
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000688
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08