Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals

• Status: Completed
• Trial end date: 1995-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Zidovudine

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.