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Study of Enfuvirtide in HIV-Positive Subjects

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00086710
Enrollment
26
Registered
2004-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, HIV Infections

Brief summary

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.

Interventions

DRUGFuzeon

Sponsors

Hoffmann-La Roche
CollaboratorINDUSTRY
Trimeris
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

\-

Exclusion criteria

\-

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026