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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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