NCT00000696

Brief Summary

To evaluate the anti-HIV effect of single agent versus combination therapy with zidovudine (AZT) and interferon alfa-2a (IFN-A2a), as measured by p24 protein expression, viral growth and infectivity in patients with symptomatic HIV disease. To assess the safety of low dose schedules of AZT and IFN-A2a, alone and in combination, as measured by neutrophil counts and hepatic transaminase levels. To evaluate the comparative effects of single agent versus combination therapy with AZT and IFN-A2a on CD4 cell counts and skin test reactivity. AZT is known to be an effective treatment for HIV infection. However, patients may develop reactions to AZT when it is administered for long periods of time. Combining AZT with another drug at lower doses might reduce toxicity in patients and prevent the development of drug resistant strains. IFN-A2a can reduce the growth of HIV in test tube experiments and recent studies have shown that when AZT and IFN-A2a are used together they reduce the growth of HIV more effectively than when either drug is used alone. This study will examine the effectiveness and safety of these drugs when they are given together and compare these results with the effectiveness and safety of the drugs when they are used alone.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

6 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

November 1, 1993

Completed
6 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 2, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 26, 2021

Conditions

HIV Infections

Keywords

Interferon Alfa-2aDrug Therapy, CombinationAIDS-Related ComplexZidovudine

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:
  • Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP), as aerosolized pentamidine.
  • Ibuprofen.
  • Acute therapy (7 days) with oral acyclovir.
  • Acute therapy with ketoconazole.
  • Patients must have:
  • A diagnosis of AIDS related complex as well as defined symptoms within 12 months of study entry in the absence of concurrent illness or conditions other than HIV infection.
  • Estimated life expectancy of at least 12 weeks.
  • Positive serum p24 antigen \> 70 pg/ml. Patients may have received prior zidovudine (AZT) and / or interferon alpha therapy, provided that:
  • The total duration of treatment was \< 6 months. Patients treated \> 12 weeks but \< 6 months should have received continuous therapy (no more than 14 consecutive days or 21 total days off during the treatment period). For patients treated = or \< 12 weeks, continuous treatment means \< 7 days off total during the treatment period. For all patients, a washout period of = or \> 4 weeks must have elapsed prior to study entry. Treatment did not result in a major adverse reaction attributable to AZT or IFN-A2a such that rechallenge at a randomly assigned dosage level would be precluded.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Acquired immunodeficiency syndrome (AIDS) as defined by opportunistic infections.
  • Significant cardiac (New York Heart Association Class 3 or 4), hepatic, renal, or neurologic disorder.
  • Concurrent neoplasm other than basal cell carcinoma or in situ carcinoma of the cervix.
  • Significant neurological disorder which impairs the patient's ability to give or receive informed consent or reduces the patient's performance status to the extent that protocol requirements and self-administration of drug cannot be accurately completed.
  • Concurrent Medication:
  • Excluded:
  • All concomitant medications should be kept to a minimum.
  • Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP), other than aerosolized pentamidine.
  • Other antiretroviral agents.
  • Experimental medications.
  • Biologic response modifiers.
  • Systemic corticosteroids.
  • Cimetidine.
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

USC CRS

Los Angeles, California, 90033, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, United States

Location

Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU

New Orleans, Louisiana, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, United States

Location

University of Minnesota, ACTU

Minneapolis, Minnesota, 55455, United States

Location

Beth Israel Med. Ctr. (Mt. Sinai)

New York, New York, 10029, United States

Location

Related Publications (4)

  • Zucker ML, Huberman KT, Hirschman SZ, Mildvan D. Stability of HIV-1 p24 antigen upon prolonged storage at -70 degrees C. The ACTG 068 Collaborative Team. Int Conf AIDS. 1992 Jul 19-24;8(3):44 (abstract no PuA 6203)

    BACKGROUND

  • Mildvan D, Bassiakos Y. Zidovudine (ZDV) and interferon-alpha 2a (IFN): ongoing assessment of synergy and tolerance in early ARC patients, ACTG 068. The ACTG 068 Collaborative Group. Int Conf AIDS. 1992 Jul 19-24;8(2):B184 (abstract no PoB 3586)

    BACKGROUND

  • Mildvan D, Ruprecht R, Krown S, Pettinelli C. Methodological issues in AIDS clinical trials. Application of the combination index method in the design of a clinical antiretroviral trial: ACTG 068. J Acquir Immune Defic Syndr (1988). 1990;3 Suppl 2:S111-3 discussion S114-9. No abstract available.

    PMID: 2231291BACKGROUND

  • Mildvan D, Bassiakos Y, Zucker ML, Hyslop N Jr, Krown SE, Sacks HS, Zachary J, Paredes J, Fessel WJ, Rhame F, Kramer F, Fischl MA, Poiesz B, Wood K, Ruprecht RM, Kim J, Grossberg SE, Kasdan P, Berge P, Marshak A, Pettinelli C. Synergy, activity and tolerability of zidovudine and interferon-alpha in patients with symptomatic HIV-1 infection: AIDS Clincal Trial Group 068. Antivir Ther. 1996 Apr;1(2):77-88.

    PMID: 11321183BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAIDS-Related Complex

Interventions

Interferon alpha-2Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital 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

  • D Mildvan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
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

November 1, 1993

Last Updated

November 2, 2021

Record last verified: 2021-10

Locations

US(6)