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A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002086
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1993

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002086 on ClinicalTrials.gov Archive Site
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A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection
A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection

Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1 (Retrovir/HIVID/Wellferon) can produce complete responses (i.e., CD4 counts return to >= 800 cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To determine the antiviral effect of the combination therapies as evidenced by measures of quantitative viral load performed at select study centers only.

Secondary: To determine the effectiveness of Retrovir/HIVID and Retrovir/HIVID/Wellferon in maintaining or increasing CD4 counts and preventing disease progression as evidenced by the development of an AIDS-defining indicator disease. To determine the effect of these regimens on secondary measures of clinical status (e.g., performance score, weight change, and secondary infections) and on measures of virologic activity such as serum p24 antigen. To assess the safety and tolerance of these regimens.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Zidovudine
  • Drug: Zalcitabine
  • Drug: Interferon alfa-n1
Not Provided
Lavelle J, Haas D, Barry D, Mustafa N, Mciunnis R, Rooney J. Long-term safety and efficacy of initial triple combination therapy with ZDV, ddC and interferon alpha-n1 vs. ZDV and ddC in patients with CD4+ cell counts 300-500 cells/mm3. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:107

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
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Inclusion Criteria

Patients must have:

  • HIV infection documented by licensed ELISA confirmed by Western blot; OR positive HIV culture; OR positive HIV antigen; OR plasma viremia.
  • CD4 counts >= 300 and <= 500 cells/mm3 on two occasions within 30 days prior to study entry.

Patients < 18 years of age must have written consent of parent or guardian. The effects of the combination therapy on infants or the developing fetus are unknown. Patients are encouraged to utilize adequate contraception while enrolled in the study.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Current AIDS-defining indicator disease, including opportunistic infections, AIDS dementia, AIDS-wasting syndrome, and AIDS-associated malignancy.
  • Grade 2 or worse peripheral neuropathy.
  • Intolerance to Retrovir at 600 mg/day, HIVID at 2.25 mg/day, or any interferon-alfa product at 3.0 MU/day.
  • Significant cardiac dysfunction (NYHA grade 3 or 4).

Concurrent Medication:

Excluded:

  • Chemotherapeutic agents during the 76 weeks following study entry.
  • Cardiac glycosides, antiarrhythmics, or vasodilators.

Patients with the following prior conditions are excluded:

  • History of AIDS-defining indicator disease, including opportunistic infections, AIDS dementia, AIDS-wasting syndrome, or AIDS-associated malignancy.
  • History of grade 2 or worse peripheral neuropathy.
  • History of intolerance to Retrovir at 600 mg/day, HIVID at 2.25 mg/day, or any interferon-alfa product at 3.0 MU/day.

Prior Medication:

Excluded:

  • More than 3 months of any prior antiretroviral therapy.
  • Cytotoxic chemotherapy within 4 weeks prior to study entry.
  • Immunomodulating agents such as systemic corticosteroids, IL-2, IFN-alfa, or IFN-beta within 4 weeks prior to study entry.
  • Cardiac glycosides, antiarrhythmics, or vasodilators.

Prior Treatment:

Excluded:

  • Radiation therapy within 4 weeks prior to study entry. Current alcohol or illicit drug use that would interfere with patient compliance.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002086
052C, 03
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
October 1993

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP