Status:

COMPLETED

A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Hoffmann-La Roche

Glaxo Wellcome

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

To determine the safety and efficacy of two doses of interferon alfa-2a ( IFN alfa-2a ) in combination with zidovudine ( AZT )/zalcitabine ( ddC ) versus AZT/ddC only in patients with HIV infection an...

Detailed Description

AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites of viral replicatio...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Isoniazid for < grade 2 peripheral neuropathy (if patient is also taking 50 mg/day pyridoxine).
  • Phenytoin for < grade 2 peripheral neuropathy.
  • A 21-day course of adjuvant systemic corticosteroid therapy for moderate to severe Pneumocystis carinii pneumonia (PCP).
  • Chemoprophylaxis for PCP, candidiasis, herpes simplex infection (up to 1 g acyclovir daily), and Mycobacterium tuberculosis.

Patients must have:

  • HIV infection.
  • CD4 count < 400 cells/mm3 within 30 days prior to study entry.

NOTE:

  • Minimal Kaposi's sarcoma is allowed.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Active opportunistic infection requiring acute therapy.
  • Need for maintenance therapy for cytomegalovirus infection, toxoplasmic encephalitis, or mycobacterial infection.
  • Malignancy (other than minimal Kaposi's sarcoma) requiring therapy.
  • Grade 2 or worse peripheral neuropathy.

Concurrent Medication:

Excluded:

  • Other antiretroviral drugs, biologic response modifiers, cytotoxic chemotherapy, or investigational drugs (unless approved by the protocol chairs).
  • Recombinant erythropoietin, G-CSF, or GM-CSF.
  • Drugs that cause peripheral neuropathy, e.g., gold, hydralazine, nitrofurantoin, vincristine, cisplatin, disulfiram, and diethyldithiocarbamate (unless approved by the protocol chairs).

Concurrent Treatment:

Excluded:

  • Radiation therapy (unless approved by the protocol chairs).

Patients with the following prior conditions are excluded:

  • History of intolerance to AZT at 600 mg/day or less.
  • Unexplained temperature of 38.5 degrees C persisting for 14 days or longer.
  • Unexplained, chronic diarrhea defined as 3 or more stools per day persisting for 14 days or longer.

Prior Medication:

Excluded:

  • Acute therapy for opportunistic infection within 14 days prior to study entry.
  • Prior ddC, ddI, or IFN alfa-2a.

Active substance abuse.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

February 1 1995

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00000754

End Date

February 1 1995

Last Update

November 4 2021

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Alabama Therapeutics CRS

Birmingham, Alabama, United States, 35294

2

Ucsd, Avrc Crs

La Jolla, California, United States

3

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, United States

4

Univ. of Miami AIDS CRS

Miami, Florida, United States