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
NCT ID: NCT00000754
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
1995-02-28
Brief Summary
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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 replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects.
Detailed Description
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Patients are randomly assigned to one of three treatment arms to receive AZT/ddC alone or combined with one of two doses of IFN alfa-2a. Treatment continues for up to 12 months after enrollment of the last patient. Patients are followed at 2, 4, and 8 weeks and every 8 weeks thereafter. Mean duration of follow-up is expected to be 13 months.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Interferon alfa-2a
Zidovudine
Zalcitabine
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Glaxo Wellcome
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Fischl MA
Role: STUDY_CHAIR
Richman DD
Role: STUDY_CHAIR
Locations
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Alabama Therapeutics CRS
Birmingham, Alabama, United States
Ucsd, Avrc Crs
La Jolla, California, United States
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Countries
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References
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Fischl MA, Richman DD, Saag M, Meng TC, Squires KE, Holden-Wiltse J, Meehan PM. Safety and antiviral activity of combination therapy with zidovudine, zalcitabine, and two doses of interferon-alpha2a in patients with HIV. AIDS Clinical Trials Group Study 197. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Dec 1;16(4):247-53. doi: 10.1097/00042560-199712010-00005.
Other Identifiers
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11173
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 197
Identifier Type: -
Identifier Source: org_study_id