GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults

Completed · Phase 2

Conditions studied: Infection, Human Immunodeficiency Virus I, HIV Infection

In brief

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 48 week duration and is open to both treatment naive and experienced patients who are HIV positive. There are 3 intensive pharmacokinetic (PK) visits.

Key facts

Study ID

NCT00257621

Run by

ViiV Healthcare

People needed

30

Starts

2004-10-01

Expected to finish

2007-01-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Santa Fe, New Mexico, United States
• GSK Investigational Site — Hampton, Virginia, United States
• GSK Investigational Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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