Search / Trial NCT00000700

A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP

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

Apply for Trial

Trial Information

Current as of June 13, 2024

Completed

Keywords

United States Aids Related Opportunistic Infections Pneumonia, Pneumocystis Carinii Acquired Immunodeficiency Syndrome Zidovudine

Description

Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects. Patients are assigned at random to one of two treatment programs: (1) 1 dose of AZT given orally (PO) for 6 doses per day; (2) 2 doses of AZT PO for 4 weeks followed by 1 dose PO for the remainder of the trial.

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • All concomitant medication to minimum and record.
  • Any approved medications can be used to treat an opportunistic infection.
  • Dapsone may be used for Pneumocystis carinii pneumonia (PCP).
  • Pyrimethamine - sulfadoxine may be used for toxoplasmosis.
  • Ganciclovir for cytomegalovirus may be used for maintenance only.
  • Prophylactic therapy for PCP.
  • Concurrent Treatment:
  • Allowed:
  • Local, limited radiation therapy to isolated Kaposi's sarcoma lesions provided total area is < 5 x 5 cm and a 6-MeV electron beam or 90 kV x-ray = or < 3000 rads total is used.
  • Patients must have:
  • HIV seropositivity as confirmed by any federally licensed ELISA test kit.
  • Allowed:
  • Malignancy in past which has been in complete remission for 1 year without therapy.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with active opportunistic infections will be excluded.
  • Concurrent Medication:
  • Excluded:
  • Aspirin on a regular basis or beyond 72 hours without contacting investigator.
  • Cimetidine.
  • Flurazepam.
  • Indomethacin.
  • Ranitidine.
  • Probenecid.
  • Patients with the following are excluded:
  • Status post-Pneumocystis carinii pneumonia with symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to study entry.
  • Other concurrent neoplasms other than basal cell carcinoma of the skin.
  • Requiring blood transfusions > once per month. Last transfusion cannot have been given within 7 days of entry.
  • Active substance abuse. Unwilling to sign informed consent or to be followed at medical center where enrolled for duration of study and follow-up if necessary.
  • Prior Medication:
  • Excluded within 2 weeks of study entry:
  • Treatment for acute Pneumocystis carinii pneumonia (PCP).
  • Excluded within 30 days of study entry:
  • Other antiretroviral agents, immunomodulating agents, or corticosteroids.
  • Prior Treatment:
  • Excluded within 30 days of study entry:
  • Radiation therapy or cytotoxic chemotherapy for Kaposi's sarcoma.
  • Required:
  • Patients must be at least 2 weeks post- therapy status for acute Pneumocystis carinii pneumonia (PCP).

Attachments

readout_NCT00000700_2024-06-13.pdf

4.5 MB

NCT00000700_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

Bronx, New York, United States

New York, New York, United States

Seattle, Washington, United States

San Diego, California, United States

Rochester, New York, United States

Durham, North Carolina, United States

San Francisco, 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

Elmhurst, New York, United States

Syracuse, New York, United States

Boston, Massachusetts, United States

Los Angeles, California, United States

New York, New York, United States

Pittsburgh, Pennsylvania, United States

San Francisco, California, United States

New Orleans, Louisiana, 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

Boston, Massachusetts, United States

Bronx, 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
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
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?

Discussion 0