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A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP

Phase 3
12 Years
Not Enrolling
HIV Infections

Thank you

Trial Information

A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP

Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective
in test tube studies at varying doses. There is a need to see if lower doses result in
effective therapy with less harmful side effects.

Patients are assigned at random to one of two treatment programs: (1) 1 dose of AZT given
orally (PO) for 6 doses per day; (2) 2 doses of AZT PO for 4 weeks followed by 1 dose PO for
the remainder of the trial.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- All concomitant medication to minimum and record.

- Any approved medications can be used to treat an opportunistic infection.

- Dapsone may be used for Pneumocystis carinii pneumonia (PCP).

- Pyrimethamine - sulfadoxine may be used for toxoplasmosis.

- Ganciclovir for cytomegalovirus may be used for maintenance only.

- Prophylactic therapy for PCP.

Concurrent Treatment:


- Local, limited radiation therapy to isolated Kaposi's sarcoma lesions provided total
area is < 5 x 5 cm and a 6-MeV electron beam or 90 kV x-ray = or < 3000 rads total is

Patients must have:

- HIV seropositivity as confirmed by any federally licensed ELISA test kit.

- Allowed:

- Malignancy in past which has been in complete remission for 1 year without therapy.

Exclusion Criteria

Co-existing Condition:

Patients with active opportunistic infections will be excluded.

Concurrent Medication:


- Aspirin on a regular basis or beyond 72 hours without contacting investigator.

- Cimetidine.

- Flurazepam.

- Indomethacin.

- Ranitidine.

- Probenecid.

Patients with the following are excluded:

- Status post-Pneumocystis carinii pneumonia with symptomatic visceral Kaposi's sarcoma
(KS) or progression of KS within the month prior to study entry.

- Other concurrent neoplasms other than basal cell carcinoma of the skin.

- Requiring blood transfusions > once per month. Last transfusion cannot have been
given within 7 days of entry.

- Active substance abuse. Unwilling to sign informed consent or to be followed at
medical center where enrolled for duration of study and follow-up if necessary.

Prior Medication:

Excluded within 2 weeks of study entry:

- Treatment for acute Pneumocystis carinii pneumonia (PCP).

- Excluded within 30 days of study entry:

- Other antiretroviral agents, immunomodulating agents, or corticosteroids.

Prior Treatment:

Excluded within 30 days of study entry:

- Radiation therapy or cytotoxic chemotherapy for Kaposi's sarcoma.


- Patients must be at least 2 weeks post- therapy status for acute Pneumocystis carinii
pneumonia (PCP).

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

Fischl M

Investigator Role:

Study Chair


United States: Food and Drug Administration

Study ID:

ACTG 002



Start Date:

Completion Date:

May 1990

Related Keywords:

  • HIV Infections
  • United States
  • AIDS-Related Opportunistic Infections
  • Pneumonia, Pneumocystis carinii
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Immunologic Deficiency Syndromes



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