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A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections

Intervention: Ganciclovir (Drug)

Phase: N/A

Status: Completed

Sponsored by: Hoffmann-La Roche

Summary

To compare the safety and tolerance of oral ganciclovir at a double dose 3 times/day or a single dose 6 times/day to IV ganciclovir given for 20 weeks of maintenance therapy. To compare the time to progression of cytomegalovirus (CMV) retinitis between two regimens of oral ganciclovir and IV ganciclovir therapy given for 20 weeks of maintenance therapy. To describe the efficacy and safety of double dose versus single dose oral ganciclovir in patients who have a progression of retinitis while on the originally assigned maintenance treatment. To describe the safety, tolerance, and time to progression of retinitis during the 52 weeks of oral ganciclovir maintenance therapy in people with AIDS. To describe the safety and tolerance of oral ganciclovir maintenance therapy when given concurrently with antiretroviral treatment (e. g., zidovudine, ddI, or ddC). To describe survival of people with AIDS and CMV retinitis.

Clinical Details

Official title: A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment

Detailed description: Two hundred twenty-five patients with AIDS and CMV retinitis are eligible for enrollment in Groups A, B, and C of the study, provided that each subject has received and tolerated a therapeutic course of intravenous (IV) ganciclovir of at least 4 weeks duration resulting in stable retinitis. An additional 100 subjects who have received and tolerated a course of IV or oral ganciclovir under any clinical trial of oral ganciclovir sponsored by Syntex Research and have stable retinitis may enter into Group D of this study and receive oral ganciclovir.

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria Concurrent Medication: Allowed:

- Zidovudine except during the first 2 weeks of any oral or IV ganciclovir maintenance

therapy.

- ddI.

- ddC.

Patients must have:

- Confirmed HIV infection or diagnosis of AIDS.

- CMV retinitis of no more than 4 months duration.

- Stable retinitis.

- Understanding of the nature of the study, agree to its provisions, and sign informed

consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded:

- Persistent or clinically significant diarrhea (3 or more unformed stools/day),

nausea, or abdominal pain or other gastrointestinal symptoms or uncontrolled gastrointestinal disease.

- Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic

retinal assessment.

- Ocular conditions requiring immediate surgical correction (e. g., retinal tear or

detachment).

- Dementia, decreased mentation, or other encephalopathic signs and symptoms that would

interfere with the ability of the subject to give informed consent or comply with the protocol. Concurrent Medication: Excluded:

- Zidovudine during the first 2 weeks of any oral or IV ganciclovir maintenance

therapy.

- Antimetabolites.

- Alkylating agents.

- Selected nucleoside analogs.

- Selected cytokines.

Patients with the following prior conditions are excluded:

- Diagnosis of CMV retinitis more than 4 months prior to study entry.

- More than two prior induction treatments of IV ganciclovir (initial induction and one

re-induction are permitted). Prior Medication: Excluded:

- More than two induction treatment regimens with IV ganciclovir.

- Prior oral ganciclovir (in Groups A, B, and C only).

Locations and Contacts

Saint Paul's Hosp, Vancouver, British Columbia, Canada

East Bay AIDS Ctr, Berkeley, California 94704, United States

AIDS Clinical Research Ctr / UCLA Med Ctr, Los Angeles, California 900951793, United States

UCSD Med Ctr / Pediatrics, San Diego, California 92103, United States

Davies Med Ctr / c/o HIV Institute, San Francisco, California 94114, United States

Dr David Busch, San Francisco, California 94118, United States

Mount Zion Med Ctr, San Francisco, California 94115, United States

San Francisco Gen Hosp, San Francisco, California 941102859, United States

Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States

Miami Veterans Administration Med Ctr, Miami, Florida 33125, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States

Margo Heath - Chiozzi, Honolulu, Hawaii 96816, United States

Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll, Chicago, Illinois 60612, United States

Beth Israel Hosp, Boston, Massachusetts 02215, United States

Cornell Univ Med College, New York, New York 10021, United States

Dr Dorothy Friedberg, New York, New York 10016, United States

Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States

Oak Lawn Physicians Group, Dallas, Texas 75219, United States

Univ TX Galveston Med Branch, Galveston, Texas 77550, United States

Univ of Washington / Pacific Med Ctr, Seattle, Washington 98144, United States

Additional Information

Related publications:

Danner SA, Matheron S. Cytomegalovirus retinitis in AIDS patients: a comparative study of intravenous and oral ganciclovir as maintenance therapy. AIDS. 1996 Dec;10 Suppl 4:S7-11.


Last updated: June 23, 2005

Page last updated: August 20, 2015

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