Meningitis, CryptococcalPhase 1NCT00002316
The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
A Phase 1 study testing Lobradimil and Amphotericin B in people with Meningitis, Cryptococcal and HIV Infections, run by Alkermes, Inc. at 11 sites in United States.
Trial summary
To evaluate the safety of escalating doses of RMP-7 administered in persons with HIV infection and cryptococcal meningitis and to determine the MTD of the drug. To evaluate the pharmacokinetics, including cerebrospinal fluid (CSF) penetration, of amphotericin B when administered with RMP-7. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningitis, Cryptococcal, HIV Infections
- What is being tested?
- Lobradimil and Amphotericin B
- How many people
- Not given
- Where
- 11 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Up to 1 mg/kg amphotericin B for the current episode of cryptococcal meningitis.
- Patients must have:
- HIV infection.
- Acute cryptococcal meningitis.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Cardiovascular disorders including congestive heart failure, uncontrolled hypertension (seated diastolic blood pressure > 95 mm Hg), or symptomatic ischemic heart disease (angina).
- Orthostatic hypotension, defined as a decrease in systolic blood pressure of >= 20 mm Hg upon standing.
- Coma.
- Other CNS disease (e.g., other intracranial infections) that may interfere with assessment of response.
Show all 13Show fewer
- Opening CSF pressure >= 350 mm or papilledema. (For patients with recurrent disease, evidence of mass effect on either MRI or CT excludes.)
- Any concurrent disease that would preclude participation in the study.
- Patients with the following prior conditions are excluded:
- History of any bleeding disorder.
- History of active renal or hepatic disease.
- Myocardial infarction within the previous 3 months.
- Stroke within the previous 3 months.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Case Western Reserve Univ
Cleveland, Ohio, 44106
Duke Univ Med Ctr
Durham, North Carolina, 27710
Univ TX Galveston Med Branch
Galveston, Texas, 775550882
East Carolina Univ School of Medicine
Greenville, North Carolina, 278584354
Pennsylvania State Univ / Hershey Med Ctr
Hershey, Pennsylvania, 17033
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
UCI Med Ctr
Orange, California, 92668
UCSD Treatment Ctr
San Diego, California, 92103
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
Bowman Gray School of Medicine
Winston-Salem, North Carolina, 271571042
About this study
Official title: Phase I Study to Evaluate the Safety and Tolerance of RMP-7 Administered With Amphotericin B to Patients With HIV Infection and Cryptococcal Meningitis
To evaluate the safety of escalating doses of RMP-7 administered in persons with HIV infection and cryptococcal meningitis and to determine the MTD of the drug. To evaluate the pharmacokinetics, including cerebrospinal fluid (CSF) penetration, of amphotericin B when administered with RMP-7.
Read the detailed description
Patients receive intravenous RMP-7 added to conventional therapy with intravenous amphotericin B (with or without flucytosine). Treatment continues for 14 days, with follow-up visits 4 and 12 weeks later.
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Being tested
- Lobradimil, Amphotericin B
- Keywords
- AIDS-Related Opportunistic Infections, Meningitis, Drug Therapy, Combination, Antifungal Agents, Acquired Immunodeficiency Syndrome, Amphotericin B
- Medical subject headings
- Meningitis, Cryptococcal, HIV Infections, AIDS-Related Opportunistic Infections, Meningitis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LobradimilDrug
Amphotericin BDrug
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.
- Other trials for Meningitis, CryptococcalStudies of the same condition, open and under way.
- 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
- Double blind
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002316
- Sponsor's protocol ID
- 131A
- Other IDs
- ALK01-006
- Status last verified
- Dec 1994
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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
- Phase I Study to Evaluate the Safety and Tolerance of RMP-7 Administered With Amphotericin B to Patients With HIV Infection and Cryptococcal Meningitis
- ClinicalTrials.gov ID
- NCT00002316
- Acronym / sponsor ID
- 131A
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Meningitis, Drug Therapy, Combination, Antifungal Agents, Acquired Immunodeficiency Syndrome, Amphotericin B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- 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 safety of escalating doses of RMP-7 administered in persons with HIV infection and cryptococcal meningitis and to determine the MTD of the drug. To evaluate the pharmacokinetics, including cerebrospinal fluid (CSF) penetration, of amphotericin B when administered with RMP-7.
Detailed description
Patients receive intravenous RMP-7 added to conventional therapy with intravenous amphotericin B (with or without flucytosine). Treatment continues for 14 days, with follow-up visits 4 and 12 weeks later.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Up to 1 mg/kg amphotericin B for the current episode of cryptococcal meningitis.
- HIV infection.
- Acute cryptococcal meningitis.
Key exclusion criteria (13 listed)
- Cardiovascular disorders including congestive heart failure, uncontrolled hypertension (seated diastolic blood pressure > 95 mm Hg), or symptomatic ischemic heart disease (angina).
- Orthostatic hypotension, defined as a decrease in systolic blood pressure of >= 20 mm Hg upon standing.
- Coma.
- Other CNS disease (e.g., other intracranial infections) that may interfere with assessment of response.
- Opening CSF pressure >= 350 mm or papilledema. (For patients with recurrent disease, evidence of mass effect on either MRI or CT excludes.)
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 |
|---|---|---|
| Lobradimil | Drug | – |
| Amphotericin B | 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 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 Lobradimil and Amphotericin B in people with Meningitis, Cryptococcal and HIV Infections, run by Alkermes, Inc. at 11 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 6 inclusion and 13 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 11 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?
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.