Clinical trial NCT00002316: The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Meningitis, Cryptococcal
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Meningitis
Drug Therapy, Combination
Antifungal Agents
Acquired Immunodeficiency Syndrome
Amphotericin B
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: Orange
country: United States
facility: UCI Med Ctr
state: California
city: San Diego
country: United States
facility: UCSD Treatment Ctr
state: California
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: Stony Brook
country: United States
facility: SUNY / Health Sciences Ctr at Stony Brook
state: New York
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Greenville
country: United States
facility: East Carolina Univ School of Medicine
state: North Carolina
city: Winston Salem
country: United States
facility: Bowman Gray School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve Univ
state: Ohio
city: Hershey
country: United States
facility: Pennsylvania State Univ / Hershey Med Ctr
state: Pennsylvania
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
Study officials:
References: