Search / Trial NCT00000989

The Safety and Effectiveness of Ganciclovir Used Alone or in Combination With Granulocyte-Macrophage Colony Stimulating Factor in the Treatment of Cytomegalovirus (CMV) of the Eye in Patients With AIDS

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Apply for Trial

Trial Information

Current as of July 23, 2024

Completed

Keywords

Retinitis Ganciclovir Drug Evaluation Drug Therapy, Combination Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Zidovudine

Description

AMENDED: In ACTG 004, among 11 AIDS patients with CMV infection receiving DHPG maintenance therapy (5 mg/kg, 5x/week) with stable white blood cells (WBC)/absolute neutrophil counts (ANC) 7 (64 percent) required dose reduction or discontinuation of both antiviral medications due to granulocytopenia when AZT (600 mg/day) was added. A mean nadir ANC of 717 cells/ml was reached at a mean of 5 weeks of concomitant DHPG/AZT therapy in these patients. While recovery of depressed ANC occurred following discontinuation of study medications, progressive CMV infection (most commonly retinitis) occurre...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Maintenance therapy for stable opportunistic infection which is not myelosuppressive.
  • Aerosolized pentamidine for prophylaxis of Pneumocystis carinii pneumonia.
  • Acyclovir or other appropriate medications for appearance of Herpes simplex virus or Varicella zoster virus infections (after enrollment in study) that require systemic therapy.
  • Medications absolutely necessary for the patient's welfare, at discretion of investigator.
  • Patients must:
  • Have a diagnosis of sight-threatening cytomegalovirus (CMV) retinitis and AIDS.
  • Have at least one pending culture for cytomegalovirus (CMV) from buffy coat and/or urine prior to study entry or previously documented CMV viremia or viruria within 6 weeks prior to study entry.
  • Be capable of giving informed consent.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following are excluded:
  • Corneal, lenticular, or vitreal opacification that precludes examination of the fundi, or evidence of other retinopathy other than cotton wool spots.
  • Concurrent Medication:
  • Excluded:
  • Systemic antiviral therapy except Zidovudine (AZT) which will be added during the extended maintenance phase of the study.
  • Foscarnet.
  • Treatment for an active AIDS-defining opportunistic infection.
  • Any potentially cytotoxic chemotherapeutic agent.
  • Patients with the following are excluded:
  • Corneal, lenticular, or vitreal opacification that precludes examination of the fundi, or evidence of other retinopathy other than cotton wool spots.
  • Prior Medication:
  • Excluded within 14 days of study entry:
  • Other immunomodulators, biologic response modifiers, or investigational agents.
  • Protocol drugs.
  • Foscarnet.
  • Any potentially cytotoxic chemotherapeutic agent.
  • Prior Treatment:
  • Excluded within 14 days of study entry:
  • Administration of cytomegalovirus hyperimmune globulin in therapeutic doses.

Attachments

readout_NCT00000989_2024-07-23.pdf

4.5 MB

NCT00000989_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Boston, Massachusetts, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0