Search / Trial NCT00001038

A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients

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

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Trial Information

Current as of June 13, 2024

Completed

Keywords

Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antiviral Agents

Description

Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV. Patients are randomized to receive BW 256U87 alone or acyclovir alone as control at either high-dose or low-dose. The acyclovir controls will provide suppressive therapy for herpes simplex infections and may affect survi...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Recommended:
  • PCP prophylaxis.
  • Allowed:
  • Any antiretroviral therapies available by prescription or through expanded access or Treatment IND programs, including combination or sequential use.
  • Chemotherapy for Kaposi's sarcoma, lymphoma, or other malignancies IF patient is hematologically stable for at least 30 days prior to study entry.
  • Discrete courses of oral or parenteral acyclovir for VZV or HSV infection, not to exceed 21 days per episode (may co-enroll on ACTG 169). For recurrent episodes, open-label acyclovir for a total of 60 days over a 12-month period is allowed. Study drug is interrupted.
  • Supportive therapies available by prescription, expanded access, or Treatment IND programs, such as G-CSF, GM-CSF, and erythropoietin.
  • Other medications necessary for the patient's welfare, at the discretion of the investigator.
  • Patients must have:
  • HIV infection or AIDS-defining conditions.
  • CD4+ count < 100 cells/mm3.
  • IgG antibodies to CMV.
  • No active CMV disease or history of CMV end-organ disease.
  • Consent of parent or guardian if less than 18 years of age.
  • Ability to comply with protocol.
  • NOTE:
  • Patients may be co-enrolled in ACTG primary infection Phase II/III studies, ACTG opportunistic infection protocols, or treatment protocols or similar studies sponsored by other research networks as long as those studies do not violate the restrictions placed on concomitant therapies and toxicity management.
  • Prior Medication:
  • Allowed:
  • PCP prophylaxis.
  • Any antiretroviral therapies available by prescription or through expanded access or Treatment IND programs, including combination or sequential use.
  • Chemotherapy for Kaposi's sarcoma, lymphoma, or other malignancies.
  • Acyclovir.
  • Supportive therapies available by prescription, expanded access, or Treatment IND programs, such as G-CSF, GM-CSF, and erythropoietin.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Nausea or vomiting that precludes oral dosing.
  • Ocular media opacities that preclude adequate visualization of fundi.
  • Pregnancy.
  • Known hypersensitivity to acyclovir.
  • Known lactose intolerance.
  • Concurrent Medication:
  • Excluded:
  • Systemic interferons and immunomodulators (including CMV hyperimmune serum/globulin and chronic corticosteroids at doses in excess of physiologic replacement).
  • Probenecid.
  • Investigational or marketed agents with potential activity against CMV, herpes simplex, and/or Varicella zoster, EXCEPT as specifically allowed.
  • Patients with the following prior condition are excluded:
  • Pre-existing necrotizing retinopathy that may interfere with a subsequent diagnosis of CMV retinitis.
  • Prior Medication:
  • Excluded:
  • Prior ganciclovir, foscarnet, or any investigational anti-CMV agent including use of foscarnet for acyclovir-resistant herpes.
  • Interferons, immunomodulators (other than colony stimulating factors), or CMV hyperimmune globulin within 30 days prior to study entry.

Attachments

readout_NCT00001038_2024-06-13.pdf

4.5 MB

NCT00001038_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

Indianapolis, Indiana, United States

Bronx, New York, United States

New York, New York, United States

Columbus, Ohio, United States

Chicago, Illinois, United States

San Diego, California, United States

Oakland, California, United States

Baltimore, Maryland, United States

Philadelphia, Pennsylvania, United States

Seattle, Washington, United States

Montreal, Quebec, Canada

Denver, Colorado, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Galveston, Texas, United States

Birmingham, Alabama, United States

St Louis, Missouri, United States

Montreal, Quebec, Canada

Chapel Hill, North Carolina, United States

San Francisco, California, United States

Los Angeles, California, United States

New Haven, Connecticut, United States

Sydney, , Australia

Calgary, Alberta, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Hvidore, , Denmark

Paris Cedex 12, , France

Berlin, , Germany

Rome, , Italy

Stockholm, , Sweden

Bern, , Switzerland

London, , United Kingdom

London, , United Kingdom

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
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Leslie Alexander
20 September 2023

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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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