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:
ViiV Healthcare
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00242879
First received: October 19, 2005
Last updated: April 1, 2013
Last verified: April 2013
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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:
Genetics Home Reference related topics:
complement factor I deficiency
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:
- 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:
Detailed Description:
-
Drug: Physician determined comparator PI + ritonavir
Drug: GW640385 + ritonavir
- Physician determined comparator PI + ritonavir
- GW640385 + ritonavir
Other Names:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242879
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| United States, Arizona | |
| GSK Investigational Site | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
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| Bakersfield, California, United States, 93301 | |
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| Denver, Colorado, United States, 80204 | |
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| Denver, Colorado, United States, 80220 | |
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| Norwalk, Connecticut, United States, 06851 | |
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| Washington, District of Columbia, United States, 20009 | |
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| Baltimore, Maryland, United States, 21201 | |
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| Hampton, Virginia, United States, 23666 | |
| Australia, New South Wales | |
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| Darlinghurst, New South Wales, Australia, 2010 | |
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| Liverpool, New South Wales, Australia, 2170 | |
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| South Yarra, Victoria, Australia, 3141 | |
| Belgium | |
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| Bruxelles, Belgium, 1000 | |
| Canada, British Columbia | |
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| Vancouver, British Columbia, Canada, V6Z 2C7 | |
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| Sainte-Foy, Quebec, Canada, G1V 4G2 | |
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| Caen, France, 14000 | |
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| La Roche Sur Yon cedex 9, France, 85025 | |
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| Lyon Cedex 02, France, 69288 | |
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| Lyon Cedex 03, France, 69437 | |
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| Muenchen, Bayern, Germany, 80335 | |
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| Frankfurt, Hessen, Germany, 60590 | |
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| Essen, Nordrhein-Westfalen, Germany, 45122 | |
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| Hamburg, Germany, 20099 | |
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| Ferrara, Emilia-Romagna, Italy, 44100 | |
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| Rimini, Emilia-Romagna, Italy, 47900 | |
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| Milano, Lombardia, Italy, 20127 | |
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| Torino, Piemonte, Italy, 10149 | |
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| Bari, Puglia, Italy, 70124 | |
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| Bagno a Ripoli (FI), Toscana, Italy, 50126 | |
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| Cascais, Portugal, 2750 | |
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| Lisboa, Portugal, 1150 | |
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| Bucharest, Romania, 021105 | |
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| United Kingdom | |
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| London, United Kingdom, EC1 7BE | |
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| London, United Kingdom, SW10 9TH | |
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 Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013