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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
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Enfuvirtide Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 78 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • 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:


  • 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:


- Prior treatment with an HIV vaccine.

Prior Treatment:


Major organ allograft.

Risk Behavior:


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.

Information from the National Library of Medicine

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

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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 Collaborators
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Study Chair: Sam Hopkins
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ClinicalTrials.gov Identifier: NCT00002228    
Other Study ID Numbers: 295A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 1999
Keywords provided by NIH AIDS Clinical Trials Information Service:
Injections, Subcutaneous
Anti-HIV Agents
peptide T20
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents