HIV InfectionsPhase 2NCT00000975
A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS
A Phase 2 study testing Itraconazole in people with HIV Infections and Histoplasmosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
Trial summary
To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Histoplasmosis
- What is being tested?
- Itraconazole
- How many people
- 30 participants
- Where
- 12 sitesUnited States
- Study dates
- Start not givento Sep 1994
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Vincristine, vinblastine, bleomycin, or interferon for Kaposi's sarcoma.
- Erythropoietin.
- Didanosine by exemption for 10 patients.
- Barbiturates.
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- Coumarin-type anticoagulants.
- Oral contraceptives.
- Digoxin.
- Methadone.
- Narcotics.
- Acyclovir.
- Acetaminophen.
- Sulfonamides.
- Trimethoprim / sulfamethoxazole.
- Pentamidine for Pneumocystis carinii pneumonia (PCP) or PCP prophylaxis.
- Topical antifungals.
- Pyrimethamine.
- Ganciclovir.
- AZT.
- Stress doses of steroids in patients with adrenal insufficiency.
- Concurrent Treatment:
- Allowed:
- Dose reduction or interruption of myelosuppressive therapy and transfusion to maintain hemoglobin of 7 or more g/dl.
- Radiation therapy.
- Patient must:
- Show laboratory evidence of HIV infection and disseminated histoplasmosis.
- Be oriented to person, place, and time.
- Be able to give written informed consent (appropriate consent must be obtained from a parent or legal guardian for patients under 18 years of age).
- Allowed:
- Abnormal liver function tests in Grade 3 toxicity range if liver biopsy shows evidence that histoplasmosis caused these abnormalities.
- Mucocutaneous candidiasis.
- Prior Medication:
- Allowed:
- Amphotericin B or ketoconazole for pulmonary histoplasmosis at least 3 months prior to study entry.
- Azidothymidine (AZT).
- Vincristine, vinblastine, bleomycin, or interferon for mucocutaneous Kaposi's sarcoma.
- Prophylaxis for Pneumocystis carinii pneumonia (PCP).
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Severely ill, or at risk of dying from histoplasmosis within the first week of treatment, as indicated by systolic blood pressure less than 90 mm Hg , or PO2 less than 60.
- Active CNS lesions, malignancies, or infections other than MAI.
- Severe malabsorption syndrome (persistent diarrhea more than 4 weeks duration with at least 4 loose stools per day accompanied by a 10 percent or greater weight loss).
- Requiring cytotoxic therapy for malignancies.
Show all 40Show fewer
- Any systemic fungal infection other than histoplasmosis.
- Systemic Mycobacterium avium intracellulare.
- Receiving treatment for other acute opportunistic infections whose signs and symptoms have not yet resolved or stabilized.
- History of allergy to or intolerance of imidazoles or azoles.
- Concurrent Medication:
- Excluded:
- All other systemic antifungal agents.
- Investigational drugs not specifically allowed.
- Oral hypoglycemics.
- Rifamycins.
- Phenytoin.
- Carbamazepine.
- Steroids in excess of physiologic replacement doses not specifically allowed.
- Cytotoxic chemotherapy.
- Discouraged:
- Antacids.
- Sucralfate.
- H2 blockers.
- Patients with the following are excluded:
- Severely ill, or at risk of dying from histoplasmosis within the first week of treatment.
- Active CNS infections, malignancies or lesions not documented to be caused by histoplasmosis, which would interfere with assessment of response.
- Unable to take oral medications reliably.
- Severe malabsorption syndrome.
- Requiring cytotoxic therapy for malignancies.
- Any systemic fungal infection other than histoplasmosis.
- Systemic Mycobacterium avium intracellulare.
- Receiving treatment for other acute opportunistic infections whose signs and symptoms have not yet resolved or stabilized.
- Prior Medication:
- Excluded for greater than 1 week within the last 3 months:
- Fluconazole.
- Itraconazole.
- SCH 39304.
- Amphotericin B greater than 1.5 mg/kg, or any other antifungal for this episode of disseminated histoplasmosis.
- Patients who the investigator feels would be undependable with regard to adherence to the protocol.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Northwestern University CRS
Chicago, Illinois, 60611
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267
The Ohio State Univ. AIDS CRS
Columbus, Ohio
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
USC CRS
Los Angeles, California, 90033
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, 70112
Cornell University A2201
New York, New York, 10021
Pitt CRS
Pittsburgh, Pennsylvania
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
Washington U CRS
St Louis, Missouri
About this study
Official title: Pilot Study To Determine the Feasibility of Itraconazole for Primary Treatment and Suppression of Relapse of Disseminated Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome
To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy.
Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
Read the detailed description
Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
At least 30 patients with AIDS and an initial episode of disseminated histoplasmosis are selected for this study. Up to 5 patients will have a diagnosis of CNS histoplasmosis. Therapy with all other systemic antifungal agents must be halted before study entry. Patients receive itraconazole for 3 days followed by daily oral doses for a total of 12 weeks. Patients who are doing well clinically, without evidence of clinical failure or dose-limiting toxicity, are permitted to continue maintenance therapy to prevent relapse at a reduced dose for an additional 12 months. Patients who are being treated for CNS histoplasmosis will continue to receive itraconazole.
- Conditions
- HIV Infections, Histoplasmosis
- Being tested
- Itraconazole
- Keywords
- AIDS-Related Opportunistic Infections, Histoplasmosis, Drug Evaluation, Antifungal Agents, Acquired Immunodeficiency Syndrome
- Medical subject headings
- HIV Infections, Histoplasmosis, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionSep 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- LJ Wheat, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000975
- Sponsor's protocol ID
- ACTG 120
- Other IDs
- 11095
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Hecht FM, Wheat J, Korzun AH, Hafner R, Skahan KJ, Larsen R, Limjoco MT, Simpson M, Schneider D, Keefer MC, Clark R, Lai KK, Jacobson JM, Squires K, Bartlett JA, Powderly W. Itraconazole maintenance treatment for histoplasmosis in AIDS: a prospective, multicenter trial. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Oct 1;16(2):100-7. doi: 10.1097/00042560-199710010-00005.
PubMed 9358104Wheat J, Hafner R, Korzun AH, Limjoco MT, Spencer P, Larsen RA, Hecht FM, Powderly W. Itraconazole treatment of disseminated histoplasmosis in patients with the acquired immunodeficiency syndrome. AIDS Clinical Trial Group. Am J Med. 1995 Apr;98(4):336-42. doi: 10.1016/s0002-9343(99)80311-8.
PubMed 7709945
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study To Determine the Feasibility of Itraconazole for Primary Treatment and Suppression of Relapse of Disseminated Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome
- ClinicalTrials.gov ID
- NCT00000975
- Acronym / sponsor ID
- ACTG 120
- Conditions
- HIV Infections, Histoplasmosis
- Keywords
- AIDS-Related Opportunistic Infections, Histoplasmosis, Drug Evaluation, Antifungal Agents, Acquired Immunodeficiency Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Janssen Pharmaceuticals
- Study completion
- Sep 1994 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy.
Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
Detailed description
Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
At least 30 patients with AIDS and an initial episode of disseminated histoplasmosis are selected for this study. Up to 5 patients will have a diagnosis of CNS histoplasmosis. Therapy with all other systemic antifungal agents must be halted before study entry. Patients receive itraconazole for 3 days followed by daily oral doses for a total of 12 weeks. Patients who are doing well clinically, without evidence of clinical failure or dose-limiting toxicity, are permitted to continue maintenance therapy to prevent relapse at a reduced dose for an additional 12 months. Patients who are being treated for CNS histoplasmosis will continue to receive itraconazole.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (38 listed)
- Vincristine, vinblastine, bleomycin, or interferon for Kaposi's sarcoma.
- Erythropoietin.
- Didanosine by exemption for 10 patients.
- Barbiturates.
- Coumarin-type anticoagulants.
Key exclusion criteria (40 listed)
- Severely ill, or at risk of dying from histoplasmosis within the first week of treatment, as indicated by systolic blood pressure less than 90 mm Hg , or PO2 less than 60.
- Active CNS lesions, malignancies, or infections other than MAI.
- Severe malabsorption syndrome (persistent diarrhea more than 4 weeks duration with at least 4 loose stools per day accompanied by a 10 percent or greater weight loss).
- Requiring cytotoxic therapy for malignancies.
- Any systemic fungal infection other than histoplasmosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itraconazole | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Background: PubMed 9358104Hecht FM, Wheat J, Korzun AH, Hafner R, Skahan KJ, Larsen R, Limjoco MT, Simpson M, Schneider D, Keefer MC, Clark R, Lai KK, Jacobson JM, Squires K, Bartlett JA, Powderly W. Itraconazole maintenance treatment for histoplasmosis in AIDS: a prospective, multicenter trial. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Oct 1;16(2):100-7. doi: 10.1097/00042560-199710010-00005.
- Background: PubMed 7709945Wheat J, Hafner R, Korzun AH, Limjoco MT, Spencer P, Larsen RA, Hecht FM, Powderly W. Itraconazole treatment of disseminated histoplasmosis in patients with the acquired immunodeficiency syndrome. AIDS Clinical Trial Group. Am J Med. 1995 Apr;98(4):336-42. doi: 10.1016/s0002-9343(99)80311-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LJ Wheat study chair
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itraconazole in people with HIV Infections and Histoplasmosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000975, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.