NCT00006316

Brief Summary

The purpose of this study is to determine whether stopping preventive histoplasmosis medications in patients who are currently receiving effective anti-HIV drugs will place them at risk for getting histoplasmosis again. Histoplasmosis is a serious opportunistic (AIDS-related) infection that responds well to antifungal medications. Before anti-HIV drugs, patients with histoplasmosis required lifelong antifungal therapy. Patients who take anti-HIV drugs for a long time may see an improvement in their immune system functions. Improved immune function may eliminate the need for long-term preventive treatment with antifungal agents. Doctors want to see if the improved immune functions allow preventive treatment for histoplasmosis to be stopped. (This study has been changed to include histoplasmosis treatment with drugs other than itraconazole.)

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

13 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

First Submitted

Initial submission to the registry

September 28, 2000

Completed
11 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

August 1, 2008

Status Verified

February 1, 2004

First QC Date

September 28, 2000

Last Update Submit

July 30, 2008

Conditions

HIV InfectionsHistoplasmosis

Keywords

AIDS-Related Opportunistic InfectionsHistoplasmosisAntifungal AgentsRecurrenceAnti-HIV Agents

Eligibility Criteria

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

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are 13 years or older.
  • Have consent of parent or guardian if under 18 years of age.
  • Have HIV infection.
  • Have 2 CD4 cell counts above 150 cells/mm3 (1 of which has been obtained within 6 months and the other within 30 days before entry). Note: The 2 CD4 counts used for eligibility must be from tests performed at least 1 week apart.
  • Have received at least 1 year of treatment for histoplasmosis. (This study has been changed to include patients who have received histoplasmosis treatment with drugs other than itraconazole.)
  • Are receiving treatment for histoplasmosis or have stopped treatment within 24 weeks of study entry.
  • Have had histoplasmosis before but are free of any signs of histoplasmosis at entry into the study.
  • Have a negative pregnancy test within 14 days of study entry.
  • Have been on anti-HIV drugs for at least 24 successive weeks and have been on a stable anti-HIV drug combination for at least 8 weeks before entry.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Have any recurrence of histoplasmosis within 4 weeks of study entry.
  • Have received medications that affect the immune system including chemotherapy or corticosteroids within the last 2 months. (This study has been changed. Patients taking IL-2 are no longer excluded.)
  • Have a systemic infection. Patients on stable preventive treatment for certain opportunistic (AIDS-related) infections for at least 3 months will be eligible.
  • Require treatment for fungal infections with systemic antifungal medications.
  • Have meningitis or brain or spinal cord damage thought to be caused by Histoplasma infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

University of California San Francisco

San Francisco, California, 941104206, United States

Location

Emory Univ

Atlanta, Georgia, 30308, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Indiana Univ Hosp

Indianapolis, Indiana, 462025250, United States

Location

Methodist Hosp of Indiana / Life Care Clinic

Indianapolis, Indiana, 46202, United States

Location

Wishard Hosp

Indianapolis, Indiana, 46202, United States

Location

Univ of Nebraska Med Ctr

Omaha, Nebraska, 681985130, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Univ of Cincinnati

Cincinnati, Ohio, 452670405, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Univ of Texas, Southwestern Med Ctr of Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

HIV InfectionsHistoplasmosisAIDS-Related Opportunistic InfectionsRecurrence

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 InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mitch Goldman

    STUDY CHAIR

  • Judy Aberg

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

September 28, 2000

First Posted

August 31, 2001

Last Updated

August 1, 2008

Record last verified: 2004-02

Locations

US(13)