Search / Trial NCT00000693

Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS

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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

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

Description

CMV retinitis is one of the most common opportunistic infections in patients with AIDS. DHPG is at present the only drug available for widespread compassionate use in the United States. Although most patients respond to treatment with DHPG, the medication does not cure the infection. Most patients will have a relapse and will require retreatment with DHPG. Because of the large relapse rate, most people treated for CMV retinitis are placed on continuous treatment with DHPG. There are two major problems associated with ongoing use of DHPG: 1) The development of a low white blood cell (WBC) co...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Prior Medication:
  • Required:
  • Patients must have successfully completed remission induction therapy with ganciclovir (minimum of 14 days of therapy) for acute cytomegalovirus (CMV) retinitis within the preceding 48 hours. Patients who show no evidence of progressive disease are considered to have met criteria for successful induction.
  • Amended to allow:
  • Investigational triazoles.
  • Human recombinant erythropoietin (Eprex).
  • Other investigational non-antiviral therapies offered through treatment IND.
  • Patients must:
  • Have HIV infection as determined by a commercially licensed ELISA test confirmed by a licensed Western blot
  • Have salvageable vision (corrected acuity of 20/100 or better) in at least one eye.
  • Be capable of signing an informed consent.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following are excluded:
  • Known or suspected allergy to one of the study medications.
  • Inability to maintain adequate hydration status.
  • Concurrent Medication:
  • Excluded:
  • Concurrent therapy with nephrotoxic agents.
  • Systemic therapy for another opportunistic infection.
  • Systemic prophylaxis for Pneumocystis carinii pneumonia (PCP).
  • Probenecid.
  • Patients are advised that validity of this trial may be jeopardized by use of other potentially antiviral or immunomodulating treatments.
  • Patients with the following are excluded:
  • Known or suspected allergy to one of the study medications.
  • Inability to maintain adequate hydration status.
  • Prior Medication:
  • Excluded within 2 weeks of study entry:
  • Steroids.
  • Cytotoxic or immunosuppressive drugs.
  • Investigational agents. (Amended to now allow these.) Immunomodulatory drugs (except ganciclovir).
  • Prior Treatment:
  • Excluded within 2 weeks of study entry:
  • Radiotherapy.
  • Risk Behavior:
  • Excluded:
  • History of unreliable drug intake and inability to cooperate in the testing procedures. Unwilling or unable to give informed consent or unwilling to sign approved consent form.

Attachments

readout_NCT00000693_2024-05-23.pdf

4.5 MB

NCT00000693_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

Chicago, Illinois, United States

Chicago, Illinois, 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

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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?

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