Search / Trial NCT00000988

A Study of BMY-27857 in Patients With AIDS or AIDS Related Complex

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

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Injections, Intravenous Drug Evaluation Administration, Oral Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents

Description

Currently, the only FDA-approved therapy for patients with AIDS or ARC is zidovudine (AZT), a drug with significant value but limited use because of toxic effects on the bone marrow. d4T has not been tested in humans, but it has inhibited the reproduction of HIV (the virus that causes AIDS) in laboratory experiments. In some studies with laboratory animals, d4T was less toxic against blood cells than AZT. A maximum tolerated dose (MTD) has been found in Phase I trials to date. An MED will be determined. The daily dose of d4T is divided into 2 portions and administered approximately 12 hour...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis.
  • TMP/SMX as an alternative prophylactic agent, 1 DS tablet orally per day.
  • Acute therapy with oral acyclovir for herpes simplex infections for no more than 7 days, providing d4t is suspended Symptomatic therapy such as analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy may be administered for toxicities as deemed necessary by the principal investigator. For therapy of fever, aspirin rather than acetaminophen should be used.
  • Concurrent Treatment:
  • Allowed:
  • Transfusion of up to 2 units of packed red blood cells every 3 weeks for grade 3 or grade 4 anemia (see Recommendations for Grading of Acute and Subacute Toxic Effects (Adults)) until patient returns to baseline from grade 3 or to baseline or grade 1 from grade 4.
  • Patient must have:
  • AIDS or AIDS related complex (CDC Group IVA or CDC Group IVC-2 with thrush or oral leukoplakia).
  • Ability to provide informed consent.
  • Availability to follow-up for at least 6 months.
  • Absence of active, AIDS-defining opportunistic infection on study entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following are excluded:
  • Active, AIDS-defining opportunistic infection.
  • Intractable diarrhea.
  • History or propensity for seizure disorders requiring anticonvulsants for control.
  • Any other clinical condition which in the opinion of the investigator would make the patient unsuitable or unable to comply with the dosing requirements.
  • Concurrent Medication:
  • Excluded:
  • Systemic therapy with this or any other antiretroviral drug (including AL-721, ddI, ddC, interferon, immunomodulating drugs) or investigational drug.
  • Ribavirin.
  • Cytotoxic anticancer therapy.
  • Therapy with any agent known as a potent inducer or inhibitor of drug-metabolizing enzymes, such as rifampin or barbiturates.
  • Systemic maintenance or chemoprophylaxis for opportunistic infections.
  • Trimethoprim / sulfamethoxazole for Pneumocystis carinii infections.
  • Acute therapy with ketoconazole for thrush.
  • Neurotoxic agents listed in the protocol.
  • Patients with the following are excluded:
  • Previous intolerance to zidovudine (AZT) as demonstrated by transfusion dependent anemia (transfusion required every 3 weeks or less and AZT-related depression of neutrophils to < 500 cells/mm3).
  • Life expectancy < 6 months.
  • Prior Medication:
  • Excluded:
  • Any other prior therapy which in the opinion of the investigator would make the patient unsuitable or unable to comply with the dosing requirements.
  • Excluded within 2 weeks of study entry:
  • Therapy with any agent known as a potent inducer or inhibitor of drug-metabolizing enzymes, such as rifampin or barbiturates.
  • Excluded within 1 month of study entry:
  • Systemic therapy with this or any other antiretroviral drug (including AL-721, interferon, immunomodulating drugs, ddI, ddC) or any investigational drug.
  • Excluded within 3 months of study entry:
  • Ribavirin.
  • Cytotoxic anticancer therapy.
  • Prior Treatment:
  • Excluded:
  • Any prior therapy which in the opinion of the investigator would make the patient unsuitable or unable to comply with the dosing requirements.
  • Preference:
  • Tolerating zidovudine (AZT) at time of study entry.
  • Active alcohol or drug abuse sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.

Attachments

readout_NCT00000988_2023-12-10.pdf

4.5 MB

NCT00000988_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

New York, New York, United States

New York, New York, 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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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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