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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00257621

Purpose

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	Intervention	Phase
HIV Infection	Drug: GW640385 Drug: Ritonavir	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Enrollment:	30
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257621

Locations

United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85006
United States, California
GSK Investigational Site
San Francisco, California, United States, 94115
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20009
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Orlando, Florida, United States, 32804
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
United States, New Mexico
GSK Investigational Site
Santa Fe, New Mexico, United States, 87505
United States, Virginia
GSK Investigational Site
Hampton, Virginia, United States, 23666
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98104

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	HPR10006
Study First Received:	November 21, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00257621 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

HIV-1 protease inhibitor GW640385 ritonavir RTV

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors

Virus Diseases
Anti-Retroviral Agents
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Ritonavir
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009