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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00100984
Other study ID # ML18021
Secondary ID
Status Terminated
Phase Phase 4
First received January 7, 2005
Last updated June 19, 2017
Start date July 21, 2004
Est. completion date July 16, 2005

Study information

Verified date December 2005
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date July 16, 2005
Est. primary completion date July 16, 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- CD4 cell count greater than 50 cells/mm^3

- HIV-1 RNA viral load greater than or equal to 5000 copies/mL

- Patients must be HIV treatment experienced

- Patients diagnosed with HIV-1 infection

Exclusion Criteria:

- Female patients must not be able to have children or must be under effective contraceptives

- Female patients who are pregnant

- Have taken enfuvirtide and/or T-1249 before

- Have serious kidney problems

- Alcohol and/or drug abuse

- Have had an organ transplant

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
FUZEON [enfuvirtide]


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

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