NCT00000985

Brief Summary

To compare the safety and effectiveness of foscarnet and vidarabine treatments for AIDS patients who have herpes simplex virus infections that are resistant to standard treatment with acyclovir. Foscarnet is a drug that inhibits viruses and has been shown to be effective against infection with Cytomegalovirus and also against infection with the Herpes simplex virus in several patients with AIDS. Vidarabine has been shown to have activity against the Herpes simplex virus in patients who do not have AIDS, but it has not been studied in patients who do have AIDS. This study compares foscarnet and vidarabine treatments for AIDS patients who have herpes simplex infection that has not responded to therapy with acyclovir in the hope that one of these two drugs will help to stop further progression of the herpes simplex infection and may have fewer side effects.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_3

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

October 1, 1990

Completed
9.1 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 28, 2021

Conditions

Herpes SimplexHIV Infections

Keywords

VidarabinePhosphonoacetic AcidHerpes SimplexFoscarnetAcyclovirAcquired Immunodeficiency Syndrome

Interventions

VidarabineDRUG
AcyclovirDRUG
Foscarnet sodiumDRUG

Eligibility Criteria

Age13 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed for phase B:
  • Aerosolized pentamidine prophylaxis for Pneumocystis carinii pneumonia (PCP).
  • Prior Medication:
  • Allowed for phase A:
  • Ganciclovir. Patients receiving this drug at the time of study enrollment must discontinue the drug at the time of enrollment and for the duration of the study period.

You may not qualify if:

  • Co-existing Condition:
  • For phase A, patients with pre-existing severe neurologic impairment such as seizure disorder or marked or incapacitating ataxia are excluded.
  • Concurrent Medication:
  • Excluded upon entry into phase B:
  • Ganciclovir.
  • Immunomodulators.
  • Probenecid.
  • Ciprofloxacin.
  • Allopurinol.
  • Zidovudine (AZT).
  • Antiretrovirals.
  • Other investigational agents.
  • Acyclovir for another labeled indication.
  • Potentially nephrotoxic agents.
  • Patients will be excluded from the study for the following reasons:
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612, United States

Location

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, 02215, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98105, United States

Location

Related Publications (2)

  • Safrin S, Crumpacker C, Chatis P, Davis R, Hafner R, Rush J, Kessler HA, Landry B, Mills J. A controlled trial comparing foscarnet with vidarabine for acyclovir-resistant mucocutaneous herpes simplex in the acquired immunodeficiency syndrome. The AIDS Clinical Trials Group. N Engl J Med. 1991 Aug 22;325(8):551-5. doi: 10.1056/NEJM199108223250805.

    PMID: 1649971BACKGROUND

  • Safrin S, Crumpacker C, Chatis P, Davis R, Hafner R, Rush J, Kessler H, Landry B, Mills J. ACTG 095: a randomized comparison of foscarnet (FOS) vs. Vidarabine (ARA-A) for treatment of acyclovir (ACV)-resistant mucocutaneous herpes simplex virus (HSV) infection in patients with AIDS. Int Conf AIDS. 1991 Jun 16-21;7(1):44 (abstract no MB85)

    BACKGROUND

MeSH Terms

Conditions

Herpes SimplexHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

VidarabineAcyclovirFoscarnet

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesGuanineHypoxanthinesPurinonesPhosphonoacetic AcidAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsOrganophosphonatesOrganophosphorus Compounds

Study Officials

  • S Safrin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

October 1, 1990

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(4)