Status:
COMPLETED
GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
Lead Sponsor:
ViiV Healthcare
Conditions:
Infection, Human Immunodeficiency Virus I
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI) backbone. This study has a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- HIV-1 infected subjects.
- Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.
- Plasma HIV-1 RNA (viral load) \>/=1,000 copies/mL at Screening.
- CD4+ cell count \>/= 200 cells/mm3 at Screening.
- Be able to receive at least two of the following NRTIs (3TC, FTC, d4T, ddI or ZDV)to build a nucleoside backbone regimen.
- Willing and able to provide signed and dated written informed consent prior to study entry.
- Exclusion criteria:
- Active CDC Class C disease.
- Pregnant or breastfeeding women.
- Protocol-specified laboratory abnormalities at Screening.
- Personal or family history of autoimmune disease.
- History or current indication of thyroid dysfunction or current thyroid gland abnormalities.
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00257621
Start Date
October 1 2004
End Date
January 1 2007
Last Update
May 30 2017
Active Locations (9)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85006
2
GSK Investigational Site
San Francisco, California, United States, 94115
3
GSK Investigational Site
Washington D.C., District of Columbia, United States, 20009
4
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308