Status:

COMPLETED

The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

12+ years

Phase:

PHASE3

Brief Summary

To determine the safety and usefulness of zidovudine (AZT) for the treatment of patients with early symptomatic HIV infection or early AIDS related complex (ARC). The ability of AZT to suppress HIV, t...

Detailed Description

In one human study, patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections, improved in weight and performance, and lived longer than patients who received a placebo...

Eligibility Criteria

Inclusion Criteria

  • Patients must have a positive antibody to HIV confirmed by a federally licensed ELISA test kit.
  • The CD4 cell count must be 201 - 799 cells/mm3 measured on two separate occasions within 60 days at least 72 hours apart prior to study entry (at least 1 of 2 counts and the mean must be < 800 cells/mm3, and at least 1 of 2 counts and the mean must be > 200 cells/mm3). The last count must be within 14 days of study entry.

Concurrent Medication:

Allowed:

  • Acetaminophen and acetaminophen products but use should be minimized. Continuous use for > 72 hours is discouraged.
  • Aerosolized pentamidine.

Prior Medication:

Allowed:

  • Chemoprophylaxis for Pneumocystis carinii pneumonia with aerosolized pentamidine of 300 mg every 4 weeks through the Respirgard II nebulizer if patient has CD4(+) count < 200 cells/mm3 measured on 2 determinations at least 48 hours apart.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Other antiretroviral agents, biologic modifiers or corticosteroids.
  • Other experimental medications.
  • Systemic chemoprophylaxis of Pneumocystic carinii pneumonia (PCP) - aerosolized pentamidine is allowed.

Prior Medication:

Excluded:

  • Zidovudine (AZT).
  • Other antiretroviral agents.
  • Excluded within 30 days of study entry:
  • Biologic modifiers or corticosteroids.
  • Excluded within 60 days of study entry:
  • Ribavirin.

Prior Treatment:

Excluded within 30 days of study entry:

  • Blood transfusions.

Patients may not have any of the following diseases or symptoms:

  • Active oral candidiasis at entry.
  • An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome).
  • Temperature > 38.5 degrees C persisting for > 14 consecutive days or > 15 days in a 30-day interval present at entry.
  • Chronic diarrhea defined as = or > 3 liquid stools per day, persisting for > 14 days without a definable cause during the past 2 years.
  • HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence.
  • Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG.

Patients may not have any of the following diseases or symptoms:

  • Active oral candidiasis at entry.
  • An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome).
  • Temperature > 38.5 degrees C persisting for > 14 consecutive days or > 15 days in a 30-day interval present at entry.
  • Chronic diarrhea defined as = or > 3 liquid stools per day, persisting for > 14 days without a definable cause during the past 2 years.
  • HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence.
  • Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG.

Active drug or alcohol abuse.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

February 1 1995

Estimated Enrollment :

538 Patients enrolled

Trial Details

Trial ID

NCT00001011

End Date

February 1 1995

Last Update

November 4 2021

Active Locations (40)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 10 (40 locations)

1

Los Angeles County - USC Med Ctr

Los Angeles, California, United States, 90033

2

UCLA CARE Ctr

Los Angeles, California, United States, 90095

3

Palo Alto Veterans Adm Med Ctr / Stanford Univ

Palo Alto, California, United States, 94304

4

Univ of California / San Diego Treatment Ctr

San Diego, California, United States, 921036325

The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex | DecenTrialz