Search / Trial NCT00000672

An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant 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 February 21, 2024

Completed

Keywords

Didanosine Zidovudine

Description

AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicit...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Required:
  • Aerosolized pentamidine (300 mg every 4 weeks). In the event of physiological intolerance, alternative PCP prophylaxis may be trimethoprim/sulfamethoxazole 1 DS tab per day or dapsone 50 - 100 mg per day.
  • Allowed:
  • Chronic suppressive treatment for toxoplasmosis, Pneumocystis carinii pneumonia (PCP), cryptococcal meningitis, herpes simplex virus, cytomegalovirus, coccidioidomycosis, and histoplasmosis (absorption of ketoconazole or dapsone may be inhibited if given at the same time as the buffered solution of ddI, and should be taken 2 hours before or 2 hours after taking ddI; oral acidifying agents are not allowed). Isoniazid is permitted only if no acceptable alternative therapy is available. Metronidazole may be used for single courses not to exceed 14 days within consecutive 90 day intervals, the first of which begins at the initiation of the study. Erythropoietin for patients under the relevant treatment IND. Intravenous acyclovir for short courses of therapy.
  • Patients must:
  • Have documented hematologic intolerance to zidovudine (AZT).
  • Have the diagnosis of AIDS or advanced AIDS related complex (ARC).
  • Have ended treatment for acute Pneumocystis carinii pneumonia (PCP) at least 2 weeks before study entry.
  • Have previous intolerance on at least two courses of AZT therapy (one of which must have been at daily doses of 500 mg of AZT or less).
  • Be able to provide informed consent (and/or guardian as appropriate).
  • Be available for follow-up for at least 6 months.
  • Have baseline laboratory values as measured within 7 days before initial drug dosing.
  • Allowed:
  • Development of new opportunistic infections during the study - patients remain in the protocol.
  • Prior Medication:
  • Required:
  • Prior use and intolerance to zidovudine (AZT).
  • Allowed:
  • Intralesional agents.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following are excluded:
  • Presence of Kaposi's sarcoma (KS) with known or suspected visceral disease or where KS requires chemotherapy.
  • Active AIDS defining opportunistic infections not specifically allowed.
  • Intractable diarrhea.
  • Stage 2 AIDS-dementia complex.
  • History of intolerance to aerosolized pentamidine.
  • Grade 2 neuropathy, based on the Neuropathy Targeted Symptom Questionnaire, or any moderate abnormality indicative of peripheral neuropathy, particularly impaired sensation of sharp pain, light touch, or vibration in the lower extremities, distal extremity weakness, or distal extremity hyporeflexia.
  • Prior history of acute or chronic pancreatitis.
  • History of seizures within past 2 years or currently requiring anticonvulsants for control.
  • Any other clinical conditions or prior therapy which, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
  • Concurrent Medication:
  • Excluded:
  • Isoniazid (INH).
  • Patients with the following are excluded:
  • Active AIDS-defining opportunistic infections not specifically allowed.
  • Intractable diarrhea.
  • AIDS-dementia complex = or > stage 2.
  • History of intolerance to aerosolized pentamidine. Grade 2 neuropathy, based on the Neuropathy Targeted Symptom Questionnaire, or any moderate abnormality indicative of peripheral neuropathy, particularly impaired sensation of sharp pain, light touch, or vibration in the lower extremities, distal extremity weakness, or distal extremity hyporeflexia.
  • Prior history of acute or chronic pancreatitis.
  • History of seizures within past 2 years or currently requiring anticonvulsants for control.
  • Any other clinical conditions or prior therapy which, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
  • Previous participation in any Phase I ddI study.
  • Life expectancy < 6 months.
  • Prior Medication:
  • Excluded:
  • Chronic therapy for cytomegalovirus infection with ganciclovir.
  • ddI.
  • d4T.
  • ddC.
  • Excluded within 2 weeks of study entry:
  • Zidovudine (AZT).
  • Excluded within 1 month of study entry:
  • Therapy with any other antiretroviral drug or investigational agent not specifically allowed, including interferon and immunomodulating drugs.
  • Ganciclovir.
  • Neurotoxic drugs.
  • Excluded within 3 months of study entry:
  • Ribavirin.
  • Cytotoxic anticancer therapy.
  • Prior Treatment:
  • Excluded within 2 weeks of study randomization:
  • Transfusion.
  • Active alcohol or drug abuse that is sufficient, in investigator's opinion, to prevent adequate compliance with study therapy.

Attachments

readout_NCT00000672_2024-02-21.pdf

4.5 MB

NCT00000672_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

Philadelphia, Pennsylvania, United States

Los Angeles, California, United States

Indianapolis, Indiana, United States

Springfield, Massachusetts, United States

Bronx, New York, United States

New York, New York, United States

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

Chicago, Illinois, United States

Seattle, Washington, United States

Los Angeles, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

San Diego, California, United States

Worcester, Massachusetts, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Pittsburgh, Pennsylvania, United States

Houston, Texas, United States

Houston, Texas, United States

Sylmar, California, United States

Torrance, California, United States

Miami, Florida, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Bronx, New York, United States

Bronx, New York, United States

Buffalo, New York, United States

Elmhurst, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Boston, Massachusetts, United States

New York, New York, United States

San Juan, , Puerto Rico

Palo Alto, California, United States

Pittsburgh, Pennsylvania, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Stanford, California, United States

Sylmar, California, United States

Denver, Colorado, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Fort Lauderdale, Florida, United States

Hines, Illinois, United States

Wichita, Kansas, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Worcester, Massachusetts, United States

Omaha, Nebraska, United States

Bronx, New York, United States

New York, New York, United States

Winston Salem, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Hershey, Pennsylvania, United States

Knoxville, Tennessee, United States

Milwaukee, Wisconsin, United States

Tampa, Florida, United States

Galveston, Texas, United States

Salt Lake City, Utah, 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
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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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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