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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00257621
First Posted: November 23, 2005
Last Update Posted: May 30, 2017
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.
Information provided by (Responsible Party):
ViiV Healthcare
November 21, 2005
November 23, 2005
May 30, 2017
October 2004
January 2007   (Final data collection date for primary outcome measure)
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 ]
Percentage of subjects with plasma HIV-1 RNA <400 copies/ml. Incidence of serious adverse events, rash and thyroid function abnormalities. GW640385 PK parameters.
Complete list of historical versions of study NCT00257621 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
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
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Infection, Human Immunodeficiency Virus I
  • HIV Infection
  • Drug: GW640385
  • Drug: Ritonavir
    Other Name: GW640385
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2007
January 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00257621
HPR10006
No
Not Provided
Not Provided
ViiV Healthcare
ViiV Healthcare
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
ViiV Healthcare
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP