Meningitis, CryptococcalPhase 1NCT00000677
SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
A Phase 1 study testing SCH 39304 in people with Meningitis, Cryptococcal and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 28 sites in United States.
Trial summary
To assess the safety and effectiveness of SCH 39304 as primary treatment of acute cryptococcal meningitis in HIV-infected patients. Safety and effectiveness of maintenance therapy following successful treatment of acute disease are also evaluated. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Meningitis, Cryptococcal, HIV Infections
- What is being tested?
- SCH 39304
- How many people
- 50 participants
- Where
- 28 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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:
- Currently approved antiviral therapy.
- Maintenance therapy for cytomegalovirus retinitis or toxoplasmosis.
- Rifampin.
- Isoniazid.
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- Dilantin or barbiturates if investigator agrees to rigorously monitor anticonvulsant drug levels.
- Coumarin-type anticoagulants if investigator agrees to rigorously monitor prothrombin time.
- Prophylactic treatment for Pneumocystis carinii pneumonia (PCP).
- Concurrent Treatment:
- Allowed:
- Local radiotherapy for mucocutaneous Kaposi's sarcoma.
- Prior Medication:
- Allowed:
- Amphotericin B, up to 1 mg/kg, during the previous 7 days.
- Patients must be HIV positive by 2 methodologies and have either primary cryptococcal meningitis with no prior anti-cryptococcal therapy or relapsed disease after prior therapy.
- Prior therapy for cryptococcal meningitis is limited to approved drugs.
- Written informed consent either from patient or patient's parent or legal guardian is required.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- History of hypersensitivity to imidazole or azole compounds.
- Central nervous system disease.
- Acute opportunistic infection.
- Underlying conditions that in the opinion of the investigator could preclude assessment of response.
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- Concurrent Medication:
- Excluded:
- Systemic antifungal drugs other than study drug.
- Any investigational drug other than treatment IND drugs.
- Oral hypoglycemic agents.
- Oral contraceptives.
- Cytotoxic chemotherapy.
- Patients with the following are excluded:
- Unable to take oral medications.
- Concurrent central nervous system disease which in opinion of investigator would interfere with assessment of response.
- Concurrent acute opportunistic infection requiring therapy (patients who develop an acute opportunistic infection after initiation of study medication may remain on study medication).
- Prior Medication:
- Excluded within 7 days of study entry:
- Amphotericin B, > 1 mg/kg.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Emory Univ School of Medicine
Atlanta, Georgia, 30303
Med College of Georgia
Augusta, Georgia, 30912
Birmingham Veterans Administration Med Ctr
Birmingham, Alabama, 35233
Univ Hosp
Boston, Massachusetts, 02118
Erie County Med Ctr
Buffalo, New York, 14215
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
Ohio State Univ Med Ctr
Columbus, Ohio, 43210
Duke Univ Med Ctr
Durham, North Carolina, 27710
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
Univ TX Health Science Ctr
Houston, Texas, 77030
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Dr Robert Larsen
Los Angeles, California, 90033
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Beth Israel Med Ctr
New York, New York, 10003
Mount Sinai Med Ctr
New York, New York, 10029
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
Richmond AIDS Consortium
Richmond, Virginia, 23219
Univ of Rochester Medical Center
Rochester, New York, 14642
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, 10468
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
To assess the safety and effectiveness of SCH 39304 as primary treatment of acute cryptococcal meningitis in HIV-infected patients. Safety and effectiveness of maintenance therapy following successful treatment of acute disease are also evaluated.
Cryptococcal meningitis is a significant cause of illness and death in HIV-infected patients. Intravenous amphotericin B is effective for acute disease but relapse occurs in the majority of patients. Maintenance therapy is recommended but must be balanced against the multiple toxicities of the drugs used and the problems associated with the weekly administration of intravenous therapy. Treatments that are equally or more effective and less toxic than traditional methods are needed, especially oral therapy. SCH 39304 is an orally active antifungal drug that in animal studies is active against a wide range of systemic fungal infections including infections due to Cryptococcus. Features of SCH 39304 suggest that it might be of value in the treatment of cryptococcal meningitis.
Read the detailed description
Cryptococcal meningitis is a significant cause of illness and death in HIV-infected patients. Intravenous amphotericin B is effective for acute disease but relapse occurs in the majority of patients. Maintenance therapy is recommended but must be balanced against the multiple toxicities of the drugs used and the problems associated with the weekly administration of intravenous therapy. Treatments that are equally or more effective and less toxic than traditional methods are needed, especially oral therapy. SCH 39304 is an orally active antifungal drug that in animal studies is active against a wide range of systemic fungal infections including infections due to Cryptococcus. Features of SCH 39304 suggest that it might be of value in the treatment of cryptococcal meningitis.
HIV-infected patients with a diagnosis of acute cryptococcal meningitis, previously untreated or relapsed following a successfully treated acute episode, are enrolled in the study. SCH 39304 is administered orally once daily for 3 days followed by a lower dose once daily for 12 weeks. Patients who respond to primary therapy are randomized to receive SCH 39304 maintenance therapy at a higher dose once weekly or at the lower dose once daily for up to 12 months under this protocol.
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Being tested
- SCH 39304
- Keywords
- Sch 39304, AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Drug Evaluation, Antifungal Agents, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Meningitis, Cryptococcal, HIV Infections, AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 39304Drug
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningitis, CryptococcalStudies 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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Schering-Plough
- Investigators
- WG Powderly, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000677
- Sponsor's protocol ID
- ACTG 125
- Other IDs
- C89-258
- Status last verified
- Dec 1994
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Lee BL, Padula AM, Tauber MG, Chambers HF, Sande MA. Oral SCH 39304 as primary, salvage, and maintenance therapy for cryptococcal meningitis in AIDS. J Acquir Immune Defic Syndr (1988). 1992;5(6):600-4.
PubMed 1588494
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
- ClinicalTrials.gov ID
- NCT00000677
- Acronym / sponsor ID
- ACTG 125
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Keywords
- Sch 39304, AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Drug Evaluation, Antifungal Agents, Acquired Immunodeficiency Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Schering-Plough
- 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 assess the safety and effectiveness of SCH 39304 as primary treatment of acute cryptococcal meningitis in HIV-infected patients. Safety and effectiveness of maintenance therapy following successful treatment of acute disease are also evaluated.
Cryptococcal meningitis is a significant cause of illness and death in HIV-infected patients. Intravenous amphotericin B is effective for acute disease but relapse occurs in the majority of patients. Maintenance therapy is recommended but must be balanced against the multiple toxicities of the drugs used and the problems associated with the weekly administration of intravenous therapy. Treatments that are equally or more effective and less toxic than traditional methods are needed, especially oral therapy. SCH 39304 is an orally active antifungal drug that in animal studies is active against a wide range of systemic fungal infections including infections due to Cryptococcus. Features of SCH 39304 suggest that it might be of value in the treatment of cryptococcal meningitis.
Detailed description
Cryptococcal meningitis is a significant cause of illness and death in HIV-infected patients. Intravenous amphotericin B is effective for acute disease but relapse occurs in the majority of patients. Maintenance therapy is recommended but must be balanced against the multiple toxicities of the drugs used and the problems associated with the weekly administration of intravenous therapy. Treatments that are equally or more effective and less toxic than traditional methods are needed, especially oral therapy. SCH 39304 is an orally active antifungal drug that in animal studies is active against a wide range of systemic fungal infections including infections due to Cryptococcus. Features of SCH 39304 suggest that it might be of value in the treatment of cryptococcal meningitis.
HIV-infected patients with a diagnosis of acute cryptococcal meningitis, previously untreated or relapsed following a successfully treated acute episode, are enrolled in the study. SCH 39304 is administered orally once daily for 3 days followed by a lower dose once daily for 12 weeks. Patients who respond to primary therapy are randomized to receive SCH 39304 maintenance therapy at a higher dose once weekly or at the lower dose once daily for up to 12 months under this protocol.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Currently approved antiviral therapy.
- Maintenance therapy for cytomegalovirus retinitis or toxoplasmosis.
- Rifampin.
- Isoniazid.
- Dilantin or barbiturates if investigator agrees to rigorously monitor anticonvulsant drug levels.
Key exclusion criteria (20 listed)
- History of hypersensitivity to imidazole or azole compounds.
- Central nervous system disease.
- Acute opportunistic infection.
- Underlying conditions that in the opinion of the investigator could preclude assessment of response.
- Systemic antifungal drugs other than study drug.
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 |
|---|---|---|
| SCH 39304 | 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 24 Jun 2005.
- Background: PubMed 1588494Lee BL, Padula AM, Tauber MG, Chambers HF, Sande MA. Oral SCH 39304 as primary, salvage, and maintenance therapy for cryptococcal meningitis in AIDS. J Acquir Immune Defic Syndr (1988). 1992;5(6):600-4.
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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.
WG Powderly study chair
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCH 39304 in people with Meningitis, Cryptococcal and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 28 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 18 inclusion and 20 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 NCT00000677, which also lists 1 linked publication.
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 24 Jun 2005.