GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
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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.
Condition or disease
Infection, Human Immunodeficiency Virus IHIV Infection
A Pilot, Phase II, Open-label, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GW640385 When Administered With Ritonavir in Combination With NRTIs for 48 Weeks in HIV-1 Infected Adults
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
Percentage of subjects with plasma HIV-1 RNA <400 copies/ml. Incidence of serious adverse events, rash and thyroid function abnormalities. GW640385 PK parameters. [ Time Frame: throughout the study ]
Secondary Outcome Measures :
Changes over time in HIV-1 viral load and CD4+ cell counts. Incidence of adverse events and laboratory abnormalities. GW640385 and RTV PK parameters. Development of resistance in subjects with virologic failure. [ Time Frame: throughout the study ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.