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| Sponsors and Collaborators: |
Trimeris Hoffmann-La Roche |
|---|---|
| Information provided by: | Trimeris |
| ClinicalTrials.gov Identifier: | NCT00086710 |
Purpose
A total of 26 patients will be admitted to the clinic where they will be dosed with each injection device. There will be a 7-day washout between doses and a 7-10 day follow-up period.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections AIDS |
Drug: Fuzeon |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | An Open-label, Randomized, Cross-over Study in HIV-Positive Subjects to Determine and Compare the Single-dose Pharmacokinetics of Enfuvirtide after a Single 90 mg SC Administration |
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Exclusion Criteria:
-
Contacts and Locations More Information
| Study ID Numbers: | T20-405 |
| Study First Received: | July 8, 2004 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00086710 |
| Health Authority: | United States: Food and Drug Administration |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Seropositivity HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Enfuvirtide Immunologic Deficiency Syndromes |
|
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Infection |
Antiviral Agents Pharmacologic Actions Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections HIV Fusion Inhibitors |
