NCT00000687

Brief Summary

To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time. In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

July 1, 1993

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 3, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 26, 2021

Conditions

Sarcoma, KaposiHIV Infections

Keywords

Interferon Alfa-2aDrug EvaluationDrug Therapy, CombinationAcquired Immunodeficiency SyndromeZidovudine

Interventions

Interferon alfa-2aDRUG
ZidovudineDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Inhalation pentamidine for the prevention of Pneumocystis carinii pneumonia (PCP) at a dose of 300 mg once every 4 weeks.
  • AMENDED: Trimethoprim - sulfamethoxazole or dapsone only if on the maintenance phase of the study.
  • Concurrent Treatment:
  • Allowed:
  • Blood transfusions.
  • Patients must have a positive antibody to HIV by any federally licensed ELISA test. All lab tests must be within 7 days of entry into the study.

You may not qualify if:

  • Concurrent Medication:
  • Excluded:
  • Other antiretroviral agents.
  • Immunomodulators.
  • Corticosteroids.
  • Cytotoxic chemotherapy.
  • Aspirin.
  • H2 blockers.
  • Barbiturates and myelosuppressive drugs should be particularly avoided as they may interfere with the metabolism or enhance the toxicities of either zidovudine or interferon alfa-2a.
  • Other experimental medications.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy.
  • Patients with prior experience of Grade 4 toxicity to zidovudine therapy will be excluded from the study.
  • Prior Medication:
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Univ. of Miami AIDS CRS

Miami, Florida, 33136, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, 02215, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

Beth Israel Med. Ctr. (Mt. Sinai)

New York, New York, 10003, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

The Ohio State Univ. AIDS CRS

Columbus, Ohio, 43210, United States

Location

Pitt CRS

Pittsburgh, Pennsylvania, United States

Location

Related Publications (1)

  • Fischl MA, Finkelstein DM, He W, Powderly WG, Triozzi PL, Steigbigel RT. A phase II study of recombinant human interferon-alpha 2a and zidovudine in patients with AIDS-related Kaposi's sarcoma. AIDS Clinical Trials Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Apr 1;11(4):379-84. doi: 10.1097/00042560-199604010-00008.

    PMID: 8601224BACKGROUND

MeSH Terms

Conditions

Sarcoma, KaposiHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Interferon alpha-2Zidovudine

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Interferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • M Fischl

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

July 1, 1993

Last Updated

November 3, 2021

Record last verified: 2021-10

Locations

US(9)