Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Enfuvirtide
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Any antiretroviral agent, provided the regimen has not changed within 6 weeks of the screening visit.
* Antibiotics for bacterial infections.
* Prophylactic medications for P. carinii pneumonia and for M. avium, including azithromycin.
* Medications for symptomatic treatment such as antipyretics, analgesics, and antiemetics.
Patients must have:
HIV-1 seropositive status.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
Concurrent neoplasm (except for basal cell carcinoma of the skin, in situ carcinoma of the cervix, and non-disseminated stable Kaposi's sarcoma).
Concurrent Medication:
Excluded:
* Patients must not be taking any concurrent antiretroviral therapy (for at least 2 weeks prior to baseline) or the patient is to be on a stable antiretroviral regimen which has not changed for at least 6 weeks prior to baseline.
* Treatment with any of the following:
* immunomodulators, biological response modifiers, chemotherapy that cannot be discontinued for the duration of the study, astemizole, terfenadine, cisapride, triazolam, midazolam, rifampin, clarithromycin, or an investigational drug within 30 days prior to the initial visit.
Patients with the following prior conditions are excluded:
* Evidence of active opportunistic infections, or unexplained temperature greater than or equal to 38.5 Celsius for 7 consecutive days within 30 days prior to screening visit.
* Chronic diarrhea (defined as greater than 3 liquid stools per day which persists for 15 days) within 30 days prior to screening visit.
* Diagnosis of hemophilia or other clotting disorders.
Prior Medication:
Excluded:
\- Prior treatment with an HIV vaccine.
Prior Treatment:
Excluded:
Major organ allograft.
Risk Behavior:
Excluded:
Evidence of substance abuse or addiction that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing schedule and protocol evaluations.
18 Years
ALL
No
Sponsors
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Trimeris
INDUSTRY
Principal Investigators
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Sam Hopkins
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham / 1917 AIDS O/P Cln
Birmingham, Alabama, United States
UCLA School of Medicine / Ctr for Research and Education
Los Angeles, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
Quest Clinical Research
San Francisco, California, United States
IDC Research Initiative
Altamonte Springs, Florida, United States
Northwestern Univ / Infect Dis Div / Pasavant Pav 828
Chicago, Illinois, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
CRI of New England
Brookline, Massachusetts, United States
NYU Med Ctr / C & D Building
New York, New York, United States
Univ North Carolina at Chapel Hill / Dept of Medicine
Chapel Hill, North Carolina, United States
Univ of Texas / Thomas Street Clinic
Houston, Texas, United States
Countries
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Other Identifiers
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TRI-003
Identifier Type: -
Identifier Source: secondary_id
295A
Identifier Type: -
Identifier Source: org_study_id