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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Zalcitabine
Interferon alfa-n1
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Interferon-alpha

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ViRx Inc
  • Marin County Specialty Clinic
  • Georgetown Univ Med Ctr
  • Stratogen of South Florida
  • Univ of South Florida
  • Infectious Diseases Research Clinic / Indiana Univ Hosp
  • Univ of Kansas School of Medicine
  • North Shore Univ Hosp / Div of Infectious Diseases
  • Univ of Cincinnati
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Vanderbilt School of Medicine
  • Baylor College of Medicine
  • Univ of Utah School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002086
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 1993
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Zalcitabine, Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Interferon-alpha

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
256 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Zalcitabine
Intervention Type
Drug
Intervention Name(s)
Interferon alfa-n1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
Facility Name
Marin County Specialty Clinic
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Stratogen of South Florida
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Univ of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Infectious Diseases Research Clinic / Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
North Shore Univ Hosp / Div of Infectious Diseases
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Univ of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670560
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Vanderbilt School of Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
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Learn more about this trial

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

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