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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
This study has been completed.
First Received: November 2, 1999   Last Updated: July 29, 2008   History of Changes
Sponsor: Hoffmann-La Roche
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Glaxo Wellcome
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000754
  Purpose

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 and CD4 count < 400 cells/mm3.

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.


Condition Intervention Phase
HIV Infections
Drug: Interferon alfa-2a
Drug: Zidovudine
Drug: Zalcitabine
Phase II

Study Type: Interventional
Study Design: Treatment, Safety Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 60
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 replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000754

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Sponsors and Collaborators
Hoffmann-La Roche
Glaxo Wellcome
Investigators
Study Chair: Fischl MA
Study Chair: Richman DD
  More Information

Additional Information:
Publications:
Study ID Numbers: ACTG 197
Study First Received: November 2, 1999
Last Updated: July 29, 2008
ClinicalTrials.gov Identifier: NCT00000754     History of Changes
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Zalcitabine
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Interferon-alpha

Additional relevant MeSH terms:
Antimetabolites
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Interferon Type I, Recombinant
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Interferon-alpha
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Growth Substances
Acquired Immunodeficiency Syndrome
Zalcitabine
Interferons
Enzyme Inhibitors
Angiogenesis Inhibitors
Antiviral Agents

ClinicalTrials.gov processed this record on February 08, 2010