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
  Purpose

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.


Condition Intervention Phase
Infection, Human Immunodeficiency Virus I
HIV-1 Infection
Drug: Physician determined comparator PI + ritonavir
Drug: GW640385 + ritonavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Enrollment: 130
Study Start Date: August 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Physician determined comparator PI + ritonavir Drug: GW640385 + ritonavir
    Other Names:
    • Physician determined comparator PI + ritonavir
    • GW640385 + ritonavir
Detailed Description:

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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242879

  Show 70 Study Locations
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: NCT00242879     History of Changes
Other Study ID Numbers: HPR20001
Study First Received: October 19, 2005
Last Updated: April 1, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

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

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
Protease Inhibitors
Ritonavir
HIV 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 August 18, 2014