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A Study of T-20 in HIV-Positive Adults

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enfuvirtide
Sponsored by
Trimeris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Injections, Subcutaneous, HIV-1, Anti-HIV Agents, peptide T20

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham / 1917 AIDS O/P Cln
  • UCLA School of Medicine / Ctr for Research and Education
  • San Francisco Gen Hosp
  • Quest Clinical Research
  • IDC Research Initiative
  • Northwestern Univ / Infect Dis Div / Pasavant Pav 828
  • Johns Hopkins Hosp
  • CRI of New England
  • NYU Med Ctr / C & D Building
  • Univ North Carolina at Chapel Hill / Dept of Medicine
  • Univ of Texas / Thomas Street Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Trimeris
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1. Study Identification

Unique Protocol Identification Number
NCT00002228
Brief Title
A Study of T-20 in HIV-Positive Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Trimeris

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Injections, Subcutaneous, HIV-1, Anti-HIV Agents, peptide T20

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
78 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Enfuvirtide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham / 1917 AIDS O/P Cln
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UCLA School of Medicine / Ctr for Research and Education
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951793
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Northwestern Univ / Infect Dis Div / Pasavant Pav 828
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
CRI of New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
NYU Med Ctr / C & D Building
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Univ North Carolina at Chapel Hill / Dept of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Univ of Texas / Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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A Study of T-20 in HIV-Positive Adults

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