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Sponsored by: |
Trimeris |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002228 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Pharmacokinetics Study |
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 |
Estimated Enrollment: | 78 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
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 with the following prior conditions are excluded:
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.
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 |
Study ID Numbers: | 295A, TRI-003 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002228 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Injections, Subcutaneous HIV-1 Anti-HIV Agents peptide T20 |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Enfuvirtide |
Virus Diseases HIV Seropositivity Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections HIV Fusion Inhibitors |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Enfuvirtide Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections HIV Fusion Inhibitors |