ClinicalTrials.gg
CompletedNCT00002316Updated Jun 24, 2005

The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis

A Phase 1 interventional study of Lobradimil and Amphotericin B in Meningitis, Cryptococcal and HIV Infections, sponsored by Alkermes, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Alkermes, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Meningitis, Cryptococcal
  • HIV Infections

Keywords

  • AIDS-Related Opportunistic Infections
  • Meningitis
  • Drug Therapy, Combination
  • Antifungal Agents
  • Acquired Immunodeficiency Syndrome
  • Amphotericin B
03

In context

Meningitis, Cryptococcal

54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.

Browse Meningitis, Cryptococcal studies →

Lead sponsor

Alkermes, Inc. is the lead sponsor of 83 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Concurrent Medication:

Allowed:

  • Up to 1 mg/kg amphotericin B for the current episode of cryptococcal meningitis.

Patients must have:

  • infection.
  • Acute cryptococcal meningitis.

Exclusion criteria

Exclusion Criteria

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.
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Masking
Double

Interventions

06

Study locations

11 sites
  • Los Angeles County - USC Med Ctr
    Los Angeles, California 90033, United States
  • UCI Med Ctr
    Orange, California 92668, United States
  • UCSD Treatment Ctr
    San Diego, California 92103, United States
  • Univ of Kansas School of Medicine
    Wichita, Kansas 67214, United States
  • SUNY / Health Sciences Ctr at Stony Brook
    Stony Brook, New York 117948153, United States
  • Duke Univ Med Ctr
    Durham, North Carolina 27710, United States
  • East Carolina Univ School of Medicine
    Greenville, North Carolina 278584354, United States
  • Bowman Gray School of Medicine
    Winston Salem, North Carolina 271571042, United States
  • Case Western Reserve Univ
    Cleveland, Ohio 44106, United States
  • Pennsylvania State Univ / Hershey Med Ctr
    Hershey, Pennsylvania 17033, United States
  • Univ TX Galveston Med Branch
    Galveston, Texas 775550882, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002316
Lead sponsor
Alkermes, Inc.
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Amphotericin B

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