Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000736

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

3200

Expected to finish

1995-02-01

Last updated by the study team

2021-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• Summitt Med Ctr / San Francisco Gen Hosp — Oakland, California, United States
• Palo Alto Veterans Adm Med Ctr / Stanford Univ — Palo Alto, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States
• Stanford at Kaiser / Kaiser Permanente Med Ctr — San Francisco, California, United States
• Children's Hosp of San Francisco — San Francisco, California, United States
• San Francisco AIDS Clinic — San Francisco, California, United States
• Stanford Univ School of Medicine — Stanford, California, United States
• Harbor UCLA Med Ctr — Torrance, California, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• St Louis Regional Hosp / St Louis Regional Med Ctr — St Louis, Missouri, United States
• SUNY / Erie County Med Ctr at Buffalo — Buffalo, New York, United States
• City Hosp Ctr at Elmhurst / Mount Sinai Hosp — Elmhurst, New York, United States
• Beth Israel Med Ctr / Peter Krueger Clinic — New York, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Cornell Univ Med Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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