A Study of T-20 in HIV-Positive Adults
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1999
History of Changes
The purpose of this study is to see if it is safe and effective to give T-20 to HIV-positive adults. T-20 is an anti-HIV drug.
Drug : Enfuvirtide
Primary Purpose: Treatment
|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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Patients are randomly placed into 1 of 6 groups: 4 dose levels of T-20 are given by subcutaneous infusion and 2 by subcutaneous injection. The entire study lasts 7 weeks; including a 2-week screening period, followed by 28 days of treatment and 1 week of follow-up.Eligibility
|Ages Eligible for Study:||18 Years and older|
|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 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.
- 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.
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 with the following prior conditions are excluded:
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.
Contacts and LocationsChoosing 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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002228
Locations Show More
|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|
Sponsors and CollaboratorsTrimeris
|Study Chair:||Sam Hopkins|
|ClinicalTrials.gov Identifier:||NCT00002228 History of Changes|
|Other Study ID Numbers:||295A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Injections, Subcutaneous
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on January 16, 2018
This information is provided by ClinicalTrials.gov.