Search / Trial NCT00000729

A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease

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

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Trial Information

Current as of November 28, 2023

Completed

Keywords

Virus Replication Infusions, Intravenous Dose Response Relationship, Drug Foscarnet Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents Cd4 Positive T Lymphocytes

Description

Although zidovudine (AZT) has been effective in treating some AIDS patients, AZT has toxic effects in many patients and other means of treating HIV-infected persons need to be evaluated. In vitro (test tube) studies have shown that the human herpes viruses are inhibited by foscarnet and that a number of retroviruses, including HIV, are sensitive to it. It is hoped that treatment of HIV-infected individuals with foscarnet during an early phase of HIV infections will reduce the risk of developing AIDS. Patients are divided into three groups: (1) asymptomatic patients with or without persiste...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine for secondary Pneumocystis carinii pneumonia (PCP) prophylaxis.
  • Short course therapy with oral acyclovir (ACV) = or < 7 days. Short course therapy with ketoconazole = or < 7 days for patients who are not responding to any other therapy.
  • Flurazepam.
  • Diphenhydramine.
  • Prior Medication:
  • Allowed:
  • Systemic therapy, prophylaxis or maintenance for an AIDS-defining opportunistic infection.
  • Patients with any of the following findings may be included:
  • Asymptomatic HIV patients with or without lymphadenopathy.
  • Patients with AIDS as defined by the CDC surveillance case definitions.
  • Patients with past or present mild to moderate signs or symptoms consistent with HIV infection.
  • p24 antigen in the serum = or > 60 pg/ml.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following will be excluded:
  • Ongoing systemic therapy / prophylaxis / maintenance for an AIDS-defining opportunistic infection.
  • Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with concurrent neoplasms other than KS or basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • Cytomegalovirus (CMV) retinitis.
  • AIDS dementia.
  • Concurrent Medication:
  • Excluded:
  • Antiretrovirals.
  • Immunomodulatory agents.
  • Corticosteroids Other systemic antiviral or antimicrobial agents.
  • Experimental medications.
  • Excluded on chronic basis and discouraged for > 72 hours:
  • Acetaminophen.
  • Narcotics.
  • Aspirin.
  • Concurrent Treatment:
  • Excluded:
  • Transfusion dependency or requirement of 2 units of blood more than once per month.
  • Patients with the following will be excluded:
  • Ongoing systemic therapy / prophylaxis / maintenance for an AIDS-defining opportunistic infection.
  • Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with concurrent neoplasms other than KS or basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • Cytomegalovirus (CMV) retinitis.
  • AIDS dementia.
  • Prior Medication:
  • Excluded within 30 days of study entry:
  • Antiretroviral agents (except ribavirin).
  • Immunomodulatory agents.
  • Excluded within 60 days of study entry:
  • Ribavirin.
  • The last blood transfusion cannot have been given within 2 weeks of entry.
  • Active substance abuse which could impair compliance with the protocol.

Attachments

readout_NCT00000729_2023-11-28.pdf

4.5 MB

NCT00000729_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

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

Seattle, Washington, United States

San Diego, California, United States

Elmhurst, New York, United States

Stony Brook, New York, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Los Angeles, California, 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
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4 stars
6
3 stars
2
2 stars
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1 stars
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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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