A Study of T-20 in HIV-Positive Adults

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002228
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999
  Purpose

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 Intervention Phase
HIV Infections
Drug: Enfuvirtide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
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 NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 78
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002228

Locations
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
Quest Clinical Research
San Francisco, California, United States, 94115
San Francisco Gen Hosp
San Francisco, California, United States, 94110
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
Trimeris
Investigators
Study Chair: Sam Hopkins
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002228     History of Changes
Other Study ID Numbers: 295A, TRI-003
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Injections, Subcutaneous
HIV-1
Anti-HIV Agents
peptide T20

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014