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A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus


N/A
13 Years
N/A
Not Enrolling
Both
Cytomegalovirus Infections, HIV Infections

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Trial Information

A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Topical or ophthalmic nucleoside analogs.

Patients must have:

- Confirmation of HIV infection.

- Documented CMV infection.

- No past or present CMV disease (e.g., retinitis, colitis, esophagitis).

- Adequate visualization of the retina of both eyes by ophthalmologist.

- CD4 count <= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining
opportunistic infection or chronic gynecologic infection) OR CD4 count <= 100
cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or
chronic gynecologic infection).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Presence of gastrointestinal disease or symptoms not controlled with medications
(e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4
weeks that is not controllable with medication).

- Inability to comply with protocol.

Concurrent Medication:

Excluded:

- The following nucleoside analogs:

- IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at
doses > 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine.

- FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal
antibody, HPMPC.

- Imipenem-cilastatin (Primaxin).

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir.

Prior Medication:

Excluded within the past 60 days:

Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or
HPMPC.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

059D

NCT ID:

NCT00002095

Start Date:

Completion Date:

Related Keywords:

  • Cytomegalovirus Infections
  • HIV Infections
  • Ganciclovir
  • Cytomegalovirus Infections
  • Acquired Immunodeficiency Syndrome
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Cytomegalovirus Infections
  • Immunologic Deficiency Syndromes

Name

Location

Georgetown Univ Med CtrWashington, District of Columbia  20007
Kaplan Cancer Ctr / New York Univ Med CtrNew York, New York  10016
AIDS Research Consortium of AtlantaAtlanta, Georgia  30308
Mount Zion Med CtrSan Francisco, California  94115
Beth Israel HospBoston, Massachusetts  02215
San Francisco Veterans Administration Med CtrSan Francisco, California  94121
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med CollChicago, Illinois  60612
East Bay AIDS CtrBerkeley, California  94705
Kraus - Beer Med GroupLos Angeles, California  90028
UCSDSan Diego, California  92103
Davies Med Ctr / c/o HIV InstituteSan Francisco, California  94114
Harbor - UCLA Med CtrTorrance, California  90502
Community Research InitiativeCoral Gables, Florida  33146
St Lukes - Roosevelt Hosp CtrNew York, New York  10019
Cornell Univ Med College / New York HospNew York, New York  10021
Buckley Braffman Stern Med AssociatesPhiladelphia, Pennsylvania  19107
Univ of Pittsburgh / Graduate School of Public HealthPittsburgh, Pennsylvania  15261
Oak Lawn Physicians GroupDallas, Texas  75219
Infectious Diseases Association of HoustonHouston, Texas  77030