A Study of T-20 in HIV-Positive Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002228|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Enfuvirtide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||78 participants|
|Official Title:||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|
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
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).
- 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 treatment with an HIV vaccine.
Major organ allograft.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002228
|United States, Alabama|
|Univ of Alabama at Birmingham / 1917 AIDS O/P Cln|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|UCLA School of Medicine / Ctr for Research and Education|
|Los Angeles, California, United States, 900951793|
|San Francisco Gen Hosp|
|San Francisco, California, United States, 94110|
|Quest Clinical Research|
|San Francisco, California, United States, 94115|
|United States, Florida|
|IDC Research Initiative|
|Altamonte Springs, Florida, United States, 32701|
|United States, Illinois|
|Northwestern Univ / Infect Dis Div / Pasavant Pav 828|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|Johns Hopkins Hosp|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|CRI of New England|
|Brookline, Massachusetts, United States, 02445|
|United States, New York|
|NYU Med Ctr / C & D Building|
|New York, New York, United States, 10016|
|United States, North Carolina|
|Univ North Carolina at Chapel Hill / Dept of Medicine|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Texas|
|Univ of Texas / Thomas Street Clinic|
|Houston, Texas, United States, 77030|
|Study Chair:||Sam Hopkins|
|Other Study ID Numbers:||
|First Posted:||August 31, 2001 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||April 1999|
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action