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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00257621
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
ViiV Healthcare

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 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 Intervention/treatment Phase
Infection, Human Immunodeficiency Virus I HIV Infection Drug: GW640385 Drug: Ritonavir Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Ritonavir

Intervention Details:
  • Drug: GW640385
  • Drug: Ritonavir
    Other Name: GW640385

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00257621

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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, D.C., 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
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline

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Responsible Party: ViiV Healthcare Identifier: NCT00257621     History of Changes
Other Study ID Numbers: HPR10006
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

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

Additional relevant MeSH terms:
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Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors