San Francisco, California 94115

  • HIV Infections

Purpose:

To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the safety and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT). (Patients utilizing treatment with other anti-retroviral drugs will be considered for study entry on a case by case basis.) To determine survival in this group of patients with AIDS and CMV retinitis.


Criteria:

Inclusion Criteria Concurrent Medication: Allowed: - Topical acyclovir. - Selected cytokines. - Allowed after the first 4 weeks of ganciclovir: - Zidovudine (AZT) at a reduced dose (500 mg/day) in patients who have tolerated ganciclovir without grade 3/4 hematological toxicity. - Other anti-retrovirals after consultation with the Syntex study monitor. Patients must have the following: - AIDS and newly diagnosed Cytomegalovirus (CMV) retinitis. - An understanding of the nature of the study, agreement to its provisions, and willingness to sign the informed consent approved by the appropriate institutions review board, and Syntex. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk, or greater than 3000 microns from the fovea). - Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment. - Ocular conditions requiring immediate surgical correction (eg: - retinal tear or detachment). - Demonstrated hypersensitivity to acyclovir or ganciclovir. - Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to comply with the protocol. Concurrent Medication: Excluded: - Antimetabolites. - Alkylating agents. - Nucleoside analogs (excluding selected anti-retroviral agents). - Imipenem-cilastatin. - Interferons. - Selected cytokines. - Acyclovir (except topical acyclovir). Patients with the following are excluded: - Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk or greater than 3000 microns from the fovea). - Concomitant conditions or diseases described in Exclusion Co-Existing Conditions. Prior Medication: Excluded within 1 month of study entry: - Previous treatment with anti-cytomegalovirus therapy (e.g., ganciclovir, foscarnet or CMV hyperimmune globulin).


NCT ID:

NCT00002034


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

San Francisco, California 94115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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