A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults

This study has been terminated.
Sponsor:
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00242879
First received: October 19, 2005
Last updated: April 1, 2013
Last verified: April 2013

October 19, 2005
April 1, 2013
August 2005
June 2007   (final data collection date for primary outcome measure)
  • Time averaged change in plasma HIV-1 RNA over 16 wks
  • Proportion of subjects achieving the target pharmacokinetic (PK) GW640385 drug levels
  • Change in laboratory parameters
Time averaged change in plasma HIV-1 RNA over 16 wks. Proportion of subjects achieving the target pharmacokinetic (PK) GW640385 drug levels. Change in laboratory parameters.
Complete list of historical versions of study NCT00242879 on ClinicalTrials.gov Archive Site
  • Assessments of HIV viral load changes
  • GW640385 and RTV pharmacokinetic measurements
  • The incidence of adverse events
  • Changes in laboratory measurements
  • ECG measurements
  • HIV viral resistance assessment
  • Immunologic measures
Assessments of HIV viral load changes. GW640385 and RTV phamacokinetic measurements. The incidence of adverse events. Changes in laboratory measurements. ECG measurements. HIV viral resistance assessment. Immunologic measures.
Not Provided
Not Provided
 
A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults
See Detailed Description

This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.

A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate the Short-Term Safety, PK and Antiviral Activity of Four Dosing Regimens of GW640385/rtv Therapy Compared to Open-label Current Protease Inhibitor (PI) Therapy in HIV-1, PI-Experienced Adults for 2 wks with Long-Term Evaluation (>48 wks) of Safety, PK and Antiviral Activity of Selected GW640385/rtv Dosing Regimen(s) vs. a RTV-boosted, PI Containing Regimen

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infection, Human Immunodeficiency Virus I
  • HIV-1 Infection
  • Drug: Physician determined comparator PI + ritonavir
  • Drug: GW640385 + ritonavir
    Other Names:
    • Physician determined comparator PI + ritonavir
    • GW640385 + ritonavir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
130
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion criteria:

  • 18+ years of age (or =16 years of age for non-EU countries, according to local requirements).
  • 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.
  • Evidence of at least 2 multi-PI resistant mutations at Screening or within 3 months of Screening.
  • Subjects must have been receiving the same anti-HIV medicines that they are on currently for at least 8 weeks prior to Screening; these anti-HIV medicines will include a single protease inhibitor (PI) in combination with a low dose of ritonavir (i.e., a ritonavir-boosted PI). However, the current PI cannot be tipranavir.
  • Able to understand and follow protocol requirements, instructions and protocol-stated restrictions.
  • Be willing and able to provide signed and dated written informed consent prior to study entry.

Exclusion criteria:

  • Subjects cannot change their anti-HIV medicines between Screening and Day 1 Visit.
  • Subjects can not be receiving dual ritonavir-boosted PIs, non-nucleoside reverse transcriptase inhibitors (NNRTIs) or Tipranavir at Screening.
  • Active CDC Class C disease at screening.
  • Pregnant or breastfeeding women.
  • Protocol-specified laboratory abnormalities at Screening.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Portugal,   Puerto Rico,   Romania
 
NCT00242879
HPR20001
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ViiV Healthcare
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
ViiV Healthcare
April 2013

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