NCT00000754

Brief Summary

To determine the safety and efficacy of two doses of interferon alfa-2a ( IFN alfa-2a ) in combination with zidovudine ( AZT )/zalcitabine ( ddC ) versus AZT/ddC only in patients with HIV infection and CD4 count \< 400 cells/mm3. AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Geographic Reach
1 country

4 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

February 1, 1995

Completed
4.8 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 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

ZalcitabineAcquired Immunodeficiency SyndromeAIDS-Related ComplexZidovudineInterferon-alpha

Interventions

Interferon alfa-2aDRUG
ZidovudineDRUG
ZalcitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Isoniazid for \< grade 2 peripheral neuropathy (if patient is also taking 50 mg/day pyridoxine).
  • Phenytoin for \< grade 2 peripheral neuropathy.
  • A 21-day course of adjuvant systemic corticosteroid therapy for moderate to severe Pneumocystis carinii pneumonia (PCP).
  • Chemoprophylaxis for PCP, candidiasis, herpes simplex infection (up to 1 g acyclovir daily), and Mycobacterium tuberculosis.
  • Patients must have:
  • HIV infection.
  • CD4 count \< 400 cells/mm3 within 30 days prior to study entry.
  • NOTE:
  • Minimal Kaposi's sarcoma is allowed.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Active opportunistic infection requiring acute therapy.
  • Need for maintenance therapy for cytomegalovirus infection, toxoplasmic encephalitis, or mycobacterial infection.
  • Malignancy (other than minimal Kaposi's sarcoma) requiring therapy.
  • Grade 2 or worse peripheral neuropathy.
  • Concurrent Medication:
  • Excluded:
  • Other antiretroviral drugs, biologic response modifiers, cytotoxic chemotherapy, or investigational drugs (unless approved by the protocol chairs).
  • Recombinant erythropoietin, G-CSF, or GM-CSF.
  • Drugs that cause peripheral neuropathy, e.g., gold, hydralazine, nitrofurantoin, vincristine, cisplatin, disulfiram, and diethyldithiocarbamate (unless approved by the protocol chairs).
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy (unless approved by the protocol chairs).
  • Patients with the following prior conditions are excluded:
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alabama Therapeutics CRS

Birmingham, Alabama, 35294, United States

Location

Ucsd, Avrc Crs

La Jolla, California, United States

Location

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, United States

Location

Related Publications (1)

  • Fischl MA, Richman DD, Saag M, Meng TC, Squires KE, Holden-Wiltse J, Meehan PM. Safety and antiviral activity of combination therapy with zidovudine, zalcitabine, and two doses of interferon-alpha2a in patients with HIV. AIDS Clinical Trials Group Study 197. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Dec 1;16(4):247-53. doi: 10.1097/00042560-199712010-00005.

    PMID: 9402071BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Interferon alpha-2ZidovudineZalcitabine

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 NucleosidesDeoxycytidineCytidine

Study Officials

  • Fischl MA

    STUDY CHAIR

  • Richman DD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

February 1, 1995

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(4)