Search / Trial NCT00000736

Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals

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

Apply for Trial

Trial Information

Current as of July 14, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine

Description

Results from several studies show that a high percentage of people infected with HIV will eventually develop AIDS or ARC unless an effective treatment is found. Because AZT is known to prolong survival in patients with AIDS or severe ARC and has acceptable toxicity in advanced disease, it is reasonable to try it in less advanced cases. Patients entered in the study are randomly assigned to one of two doses of AZT or to placebo (inactive medication). Patients take 3 capsules 5 times a day (every 4 hours from 8 am until 12 pm). The capsules contain either AZT or placebo and are identical in...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients must:
  • Be HIV seropositive and asymptomatic.
  • Have normal neurologic exam as defined by the Micro Neuro-AIDS assessment.
  • Concurrent Medication
  • Required: Prophylaxis for Pneumocystis carinii pneumonia (PCP). Aerosolized pentamidine is preferred but if not possible, Trimethoprim / sulfamethoxazole 1 DS tablet per day or Dapsone 50 - 100 mg per day is allowed.
  • Exclusion Criteria
  • Active drug or alcohol abuse sufficient to prevent adequate compliance with study therapy in the investigator's opinion.
  • Co-existing Condition:
  • Patients with the following diseases or conditions are excluded:
  • Hemophilia.
  • Oral candida infection documented by morphology or by response to antifungal therapy within 2 years of study entry.
  • Oral hairy leukoplakia at any time prior to study entry.
  • Herpes zoster infection (including single dermatome infection) within 2 years of study entry.
  • Active diarrhea as defined by 3 or more liquid stools per day.
  • Temperature > 37.8 degrees C.
  • Grade 1 impairment on two or more items (mild AIDS dementia complex) in the ACTG Micro Neuro-AIDS Assessment.
  • Prior history of malignancy other than cutaneous basal cell carcinomas or cervical carcinoma in situ.
  • Patients with the following are excluded from entry:
  • AIDS or AIDS-related complex defining symptoms.
  • Significant, chronic underlying medical illnesses which would impair continuous participation in this 3-year clinical trial.
  • Hemophilia.
  • Prior Medication: Excluded:
  • Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP).
  • Other experimental medications.
  • Excluded within 60 days of study entry:
  • Antiretroviral drugs or immunomodulators (biologic response modifiers).
  • Excluded within 120 days of study entry:
  • Systemic corticosteroids.
  • Prior Treatment: Excluded within 3 months of study entry:
  • Blood transfusion.

Attachments

readout_NCT00000736_2024-07-14.pdf

4.5 MB

NCT00000736_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

Saint Louis, Missouri, United States

Bronx, New York, United States

New York, 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

Chicago, Illinois, United States

Seattle, Washington, United States

San Diego, California, United States

New York, New York, United States

Rochester, New York, United States

Durham, North Carolina, United States

Columbus, Ohio, United States

San Francisco, California, United States

Torrance, California, 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

Los Angeles, California, United States

New York, New York, United States

Palo Alto, California, United States

Pittsburgh, Pennsylvania, United States

San Francisco, California, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Stanford, California, United States

Washington, District Of Columbia, United States

Boston, Massachusetts, United States

Bronx, New York, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Oakland, California, United States

San Francisco, California, United States

San Francisco, 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
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