A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Roche

Status: Completed

Conditions: Cytomegalovirus Retinitis; HIV Infections

Treatments: Drug: Ganciclovir

Study type: Interventional

Funder types: Other

Identifiers

NCT00002330

GANs2226

059F

Details and patient eligibility

About

To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.

Full description

Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Topical and ophthalmic nucleoside analogues.

Patients must have:

• HIV positive.
• No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
• Currently stable retinitis.

Prior Medication:

Allowed:

• Foscarnet prior to the 4 weeks of intravenous induction therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Persistent or clinically significant diarrhea, nausea, or abdominal pain.
• Severe odynophagia.
• Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
• Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
• Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
• Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.

Concurrent Medication:

Excluded:

• Acyclovir sodium (Zovirax) by any route other than topical.
• Valacyclovir.
• Brovavir.
• Vidarabine.
• Amantadine hydrochloride.
• Cytarabine.
• Idoxuridine.
• Ribavirin.
• Interferon.
• Foscarnet (non-nucleoside pyrophosphate analogue).
• CMV hyperimmune globulin.
• Soluble CD4.
• Trichosanthin (Compound Q).
• Imipenem-cilastatin.
• Isoprinosine.
• Levamisole.
• Other investigational drugs.

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir or ganciclovir.

Prior Medication:

Excluded:

• More than three induction regimens with intravenous anti-CMV therapy.
• Any prior oral ganciclovir.