NCT00000992

Brief Summary

To test the effectiveness of itraconazole in preventing the recurrence of disseminated histoplasmosis in AIDS patients. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Amphotericin B has been used to treat the infection. Although the response to this treatment is generally good, up to 90 percent of AIDS patients who have taken amphotericin B to treat their histoplasmosis infection will have a relapse (that is, they will get the disease again) within 12 months following treatment. Ketoconazole has been used to prevent relapse, but available information suggests that up to 50 percent of AIDS patients relapse even with ketoconazole treatment. A more effective therapy to prevent recurrence is needed. Itraconazole has been used successfully to treat disseminated histoplasmosis in non-AIDS patients and it is hoped that it may be more effective in preventing histoplasmosis relapse.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

8 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

June 1, 1992

Completed
7.4 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 1, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV InfectionsHistoplasmosis

Keywords

AIDS-Related Opportunistic InfectionsKetoconazoleHistoplasmosisDrug EvaluationAntifungal AgentsAcquired Immunodeficiency Syndrome

Interventions

ItraconazoleDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Itraconazole therapy must begin no more than 6 weeks after discontinuing primary amphotericin B therapy; itraconazole therapy may begin immediately after stopping the primary therapy with amphotericin B.
  • Allowed:
  • Oral contraceptives.
  • Methadone.
  • Narcotics.
  • Acyclovir.
  • Acetaminophen.
  • Sulfonamides.
  • Trimethoprim / sulfamethoxazole.
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) or PCP prophylaxis (patients with a total CD4+ count \< 200 or a history of PCP should receive PCP prophylaxis).
  • Treatment IND drugs.
  • Zidovudine.
  • Topical antifungals.
  • Discouraged:
  • +14 more criteria

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions are excluded:
  • History of allergy to, or intolerance of, imidazoles or azoles.
  • Clinical findings of active histoplasmosis.
  • Histoplasmosis of the central nervous system.
  • Inability to take oral medications reliably or severe malabsorption syndrome.
  • Malignancies requiring cytotoxic therapy.
  • Culture-proven systemic Mycobacterium tuberculosis, Mycobacterium avium-intracellulare, coccidioidomycosis, or cryptococcosis.
  • Concurrent Medication:
  • Excluded:
  • Amphotericin B as maintenance therapy.
  • Immunostimulants.
  • Ketoconazole.
  • Systemic antifungals.
  • Steroids in excess of physiologic replacement doses.
  • +29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

USC CRS

Los Angeles, California, 90033, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 46202, United States

Location

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

New Orleans, Louisiana, 70112, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

Cornell University A2201

New York, New York, 10021, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267, United States

Location

Pitt CRS

Pittsburgh, Pennsylvania, United States

Location

Related Publications (1)

  • Wheat J, Hafner R, Wulfsohn M, Spencer P, Squires K, Powderly W, Wong B, Rinaldi M, Saag M, Hamill R, Murphy R, Connolly-Stringfield P, Briggs N, Owens S; National Institute of Allergy and Infectious Diseases Clinical Trials and Mycoses Study Group Collaborators. Prevention of relapse of histoplasmosis with itraconazole in patients with the acquired immunodeficiency syndrome. Ann Intern Med. 1993 Apr 15;118(8):610-6. doi: 10.7326/0003-4819-118-8-199304150-00006.

    PMID: 8383934BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHistoplasmosisAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency Syndrome

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycosesBacterial Infections and MycosesOpportunistic InfectionsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • LJ Wheat

    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

June 1, 1992

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(8)