Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000736
First received: November 2, 1999
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

To determine if treatment with zidovudine (AZT) will delay or prevent the onset of AIDS or AIDS related complex (ARC) in individuals infected with HIV but who do not have symptoms of AIDS or ARC. Also, to compare the dose of AZT found to be useful in AIDS and severe ARC with a lower dose to see if side effects can be reduced.

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.


Condition Intervention Phase
HIV Infections
Drug: Zidovudine
Phase 3

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 3200
Study Completion Date: February 1995
Detailed 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 appearance so that neither patient nor physician knows which treatment the patient is receiving. The higher dose corresponds to the dose found to be useful in patients with AIDS or severe ARC. Patients visit the clinic every 2 weeks for the first 16 weeks, then once a month after that for evaluation. Treatment will continue until the results from the study have been analyzed, which could be as long as 3 years. If side effects occur, the dose of study medication will be decreased or temporarily stopped. If the side effects are severe, then study medication will be stopped permanently.

AMENDED: Effective with Version 4 (900226), dosing for ALL patients on Phase 2 study drug, regardless of CD4+ substudy, will proceed as open-label AZT. Original treatment assignments employed in the > 500 cells/mm3 substudy during the period from August 16, 1989 through the release of this new version. Also, toxicity management and dose modification of AZT for patients receiving Phase 2 study drug have been changed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000736

  Show 43 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Volberding P
  More Information

Additional Information:
Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000736     History of Changes
Other Study ID Numbers: ACTG 019, 10995
Study First Received: November 2, 1999
Last Updated: March 15, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014