- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002228
A Study of T-20 in HIV-Positive Adults
A Phase II Evaluation of the Safety, Plasma Pharmacokinetics, and Antiviral Activity of T-20 Administered to HIV-1 Positive Adults By Continuous Subcutaneous Infusion or Subcutaneous Injection
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Univ of Alabama at Birmingham / 1917 AIDS O/P Cln
-
-
California
-
Los Angeles, California, United States, 900951793
- UCLA School of Medicine / Ctr for Research and Education
-
San Francisco, California, United States, 94115
- Quest Clinical Research
-
San Francisco, California, United States, 94110
- San Francisco Gen Hosp
-
-
Florida
-
Altamonte Springs, Florida, United States, 32701
- IDC Research Initiative
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Univ / Infect Dis Div / Pasavant Pav 828
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosp
-
-
Massachusetts
-
Brookline, Massachusetts, United States, 02445
- CRI of New England
-
-
New York
-
New York, New York, United States, 10016
- NYU Med Ctr / C & D Building
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Univ North Carolina at Chapel Hill / Dept of Medicine
-
-
Texas
-
Houston, Texas, United States, 77030
- Univ of Texas / Thomas Street Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
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
Co-existing Condition:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sam Hopkins
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- HIV Fusion Inhibitors
- Viral Fusion Protein Inhibitors
- Enfuvirtide
Other Study ID Numbers
- 295A
- TRI-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Enfuvirtide
-
University of California, San FranciscoUniversitywide AIDS Research ProgramCompletedHIV InfectionsUnited States
-
Canadian Immunodeficiency Research CollaborativeHoffmann-La RocheCompleted
-
Hoffmann-La RocheCompletedHIV InfectionsUnited States, Puerto Rico
-
Hoffmann-La RocheCompleted
-
Hoffmann-La RocheTrimerisCompletedHIV InfectionsUnited States, Puerto Rico
-
Hoffmann-La RocheTrimerisCompleted
-
Hoffmann-La RocheTerminated
-
Hoffmann-La RocheTrimerisCompletedHIV InfectionsUnited States, Canada, Puerto Rico
-
Hoffmann-La RocheTrimerisCompletedHIV InfectionsUnited States, Australia
-
Hoffmann-La RocheCompleted