Search / Trial NCT00001015

A Study of Ribavirin in the Treatment of Patients With AIDS and AIDS-Related Problems

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

Ribavirin T Lymphocytes Acquired Immunodeficiency Syndrome Aids Related Complex

Description

RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC). Patients are selected from three patient groups: Patients with AIDS, who have not taken zidovudine (AZT) within 30 days of entry into the study and who have not been discontinued from AZT because of intolerance. Patients with AIDS related dise...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Short-course therapy (7 days) with oral acyclovir.
  • Short-course therapy (7 days) with ketoconazole.
  • Topical medications.
  • Aerosolized pentamidine for prophylactic purposes.
  • Concurrent Treatment:
  • Allowed:
  • Blood transfusions for hemoglobin toxicity.
  • Patients must have two positive HIV p24 antigen tests with titers = or > 70 picograms at least 72 hours apart and within 1 month prior to entry, the last of which must be within 2 weeks of starting therapy.
  • Prior Medication:
  • Allowed:
  • Zidovudine (AZT), without cessation of therapy required due to intolerance.
  • AZT therapy must be discontinued at least 30 days prior to study entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following are excluded:
  • Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or > 3 liquid stools per day within the past week.
  • Concurrent Medication:
  • Excluded:
  • Ongoing systemic therapy and/or prophylaxis for an AIDS-defining opportunistic infection.
  • Antineoplastic therapy.
  • Other experimental medications.
  • Systemic chemoprophylaxis for Pneumocystis carinii pneumonia.
  • Chronic (> 7 days) oral acyclovir therapy.
  • Concurrent Treatment:
  • Excluded:
  • Blood transfusions unless they are for = or > grade 3 hemoglobin toxicity.
  • Patients with the following are excluded:
  • Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or > 3 liquid stools per day within the past week.
  • Prior Medication:
  • Excluded within 30 days of study entry:
  • Antiretroviral agents including zidovudine (AZT).
  • Biologic modifiers.
  • Systemic corticosteroids.
  • Prior Treatment:
  • Excluded within 2 months of study entry:
  • Blood transfusion except for those who have taken zidovudine (AZT) who may not have received a transfusion within the previous month.
  • Active drug or alcohol abuse.

Attachments

readout_NCT00001015_2023-12-10.pdf

4.5 MB

NCT00001015_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

San Diego, California, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

San Francisco, California, United States

Boston, Massachusetts, 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

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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