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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002086
• Other study ID #: 052C
• Secondary ID: 03
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: October 1993
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Drug:
• Zidovudine

• Zalcitabine

• Interferon alfa-n1

Locations

Country	Name	City	State
United States	Univ of Cincinnati	Cincinnati	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	Infectious Diseases Research Clinic / Indiana Univ Hosp	Indianapolis	Indiana
United States	North Shore Univ Hosp / Div of Infectious Diseases	Manhasset	New York
United States	Stratogen of South Florida	Miami Beach	Florida
United States	Vanderbilt School of Medicine	Nashville	Tennessee
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Univ of Utah School of Medicine	Salt Lake City	Utah
United States	ViRx Inc	San Francisco	California
United States	Marin County Specialty Clinic	San Rafael	California
United States	Univ of South Florida	Tampa	Florida
United States	Georgetown Univ Med Ctr	Washington	District of Columbia
United States	Univ of Kansas School of Medicine	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States, 

References & Publications (1)

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