The use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of cytomegalovirus retinitis in patients with AIDS. While early clinical trials have shown that 30 mg/kg/week of DHPG is usually sufficient to delay or prevent relapse, neutropenia is a common dose-limiting problem in about 50 percent of patients. Since in vitro data have suggested that there is synergism between DHPG and interferon beta against cytomegalovirus, a reduced dose of DHPG in combination with a low dose of interferon beta may prevent relapse without causing neutropenia. If remission can be maintained with low-dose DHPG and interferon beta, maintenance therapy with a moderate dose of interferon beta alone will be evaluated in a subsequent protocol.

Condition	Treatment or Intervention
Cytomegalovirus Retinitis HIV Infections	Drug: Interferon beta-1b  Drug: Ganciclovir

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must fulfill the CDC criteria for the diagnosis of AIDS. In addition, patients must have a typical clinical picture of cytomegalovirus (CMV) retinitis, a positive CMV culture from any site, and no other possible explanation for the retinal findings (e.g., toxoplasmosis infection). Patients with AIDS in whom CMV retinitis is suspected will be examined by an ophthalmologist and, if, retinal lesions are seen, shall have a complete set of retinal photographs taken. CMV cultures of throat, buffy coat, urine, and if possible, semen will be obtained.

• Cytomegalovirus and toxoplasmosis serologic (IgG and IgM) tests will also be performed.

Exclusion Criteria

Co-existing Condition: Patients not meeting inclusion criteria are excluded.

Patients not meeting inclusion criteria are excluded.

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
      USC, Los Angeles,  California,  90033,  United States
      UCI Med Ctr, Orange,  California,  92668,  United States
      Stanford Univ School of Medicine, Stanford,  California,  94305,  United States
Texas
      Univ TX Galveston Med Branch, Galveston,  Texas,  77550,  United States

Study ID Numbers:  017A; ICM 1285
Record last reviewed:  April 1990
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002299
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08