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

This study has been completed.
Sponsor:
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00257621
First received: November 21, 2005
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  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
Infection, Human Immunodeficiency Virus I
HIV Infection
 Drug: GW640385
Drug: Ritonavir
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Ritonavir
U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

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
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW640385 Drug: Ritonavir
    Other Names:
    • Ritonavir
    • GW640385
  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
ViiV Healthcare
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00257621     History of Changes
Other Study ID Numbers: HPR10006
Study First Received: November 21, 2005
Last Updated: April 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
HIV-1 protease inhibitor GW640385 ritonavir RTV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
 Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013