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NCT00000688 Clinical Trial

A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

HIV Infections Clinical Trial

Official title:
A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000688
Other study ID # ACTG 071
Secondary ID RS-21592ICM 1697
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated March 11, 2011

Study information
Verified date October 1990
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date
Est. primary completion date February 1995
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ganciclovir

Locations
Country Name City State
United States Univ of New Mexico Hlth Sciences Ctr / Dept of Med Albuquerque New Mexico
United States Infectious Disease Physicians Inc Annandale Virginia
United States Northwestern Univ Med School Chicago Illinois
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Holmes Hosp / Univ of Cincinnati Med Ctr Cincinnati Ohio
United States Henry Ford Hosp Detroit Michigan
United States Univ TX Galveston Med Branch Galveston Texas
United States Infectious Diseases Association of Houston / Methodist Hosp Houston Texas
United States Plaza Med Ctr Houston Texas
United States Indiana Univ Hosp Indianapolis Indiana
United States Kansas City Veterans Administration Med Ctr Kansas City Missouri
United States Univ of Minnesota Minneapolis Minnesota
United States Cornell Univ Med Ctr New York New York
United States New York Univ Med Ctr / Dept of Environmental Med New York New York
United States Univ of California / San Diego Treatment Ctr San Diego California
United States Mount Zion Med Ctr San Francisco California
United States Pacific Presbyterian San Francisco California
United States Stanford at Kaiser / Kaiser Permanente Med Ctr San Francisco California
United States Mills Hosp San Mateo California
United States Washington Univ Med Ctr St Louis Missouri
United States Stanford Univ School of Medicine Stanford California
United States George Washington Univ Med Ctr Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (1)

Spector SA, Weingeist T, Pollard RB, Dieterich DT, Samo T, Benson CA, Busch DF, Freeman WR, Montague P, Kaplan HJ, et al. A randomized, controlled study of intravenous ganciclovir therapy for cytomegalovirus peripheral retinitis in patients with AIDS. AIDS Clinical Trials Group and Cytomegalovirus Cooperative Study Group. J Infect Dis. 1993 Sep;168(3):557-63. — View Citation

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