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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.

Sponsors and Collaborators: Hoffmann-La Roche
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

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Zidovudine    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons    Zalcitabine   

U.S. FDA Resources

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

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

Investigators
Study Chair:     Fischl MA    
Study Chair:     Richman DD    
  More Information


Click here for more information about Zidovudine  This link exits the ClinicalTrials.gov site
 
Click here for more information about Zalcitabine  This link exits the ClinicalTrials.gov site
 
Click here for more information about Interferon alfa-2a  This link exits the ClinicalTrials.gov site
 

Publications:

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

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

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Sexually Transmitted Diseases, Viral
Zalcitabine
Acquired Immunodeficiency Syndrome
Interferons
Zidovudine
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Interferon Alfa-2a
Retroviridae Infections
Interferon Alfa-2b

Additional relevant MeSH terms:
Antimetabolites
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Infection
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Growth Inhibitors
Angiogenesis Modulating Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 10, 2008




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