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
Public ClinicalTrials.gov record NCT00242879. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase IIB, Randomized, Multicenter, Parallel Group, Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effect of Four Blinded Dosing Regimens of GW640385X/Ritonavir Compared to Open-label Current PI Therapy in HIV-1 Infected, Protease Inhibitor Experienced Adults for 2 Weeks With Long-term Assessment (>48 Weeks) of Safety, Pharmacokinetic and Antiviral Activity of Selected 385/RTV Dosing Regimen(s) vs. a Ritonavir-boosted, Protease Inhibitor Containing Regimen
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00242879
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 130 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2005 (Type not available)
- Primary completion
- Jun 2007 (Actual)
- Completion
- Jun 2007 (Actual)
- Last update posted
- May 30, 2017
2005 – 2007
United States locations
- U.S. sites
- 31
- U.S. states
- 17
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85006 | — |
| GSK Investigational Site | Bakersfield | California | 93301 | — |
| GSK Investigational Site | Fountain Valley | California | 92708 | — |
| GSK Investigational Site | Los Angeles | California | 90046 | — |
| GSK Investigational Site | San Francisco | California | 94115 | — |
| GSK Investigational Site | San Francisco | California | 94121 | — |
| GSK Investigational Site | Denver | Colorado | 80204 | — |
| GSK Investigational Site | Denver | Colorado | 80220 | — |
| GSK Investigational Site | Norwalk | Connecticut | 06851 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20009 | — |
| GSK Investigational Site | Bradenton | Florida | 34205 | — |
| GSK Investigational Site | Fort Lauderdale | Florida | 33306 | — |
| GSK Investigational Site | Fort Lauderdale | Florida | 33308 | — |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | — |
| GSK Investigational Site | Miami Beach | Florida | 33140 | — |
| GSK Investigational Site | Chicago | Illinois | 60612-7230 | — |
| GSK Investigational Site | Chicago | Illinois | 60613 | — |
| GSK Investigational Site | Chicago | Illinois | 60657 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | — |
| GSK Investigational Site | Louisville | Kentucky | 40202 | — |
| GSK Investigational Site | Baltimore | Maryland | 21201 | — |
| GSK Investigational Site | Boston | Massachusetts | 02118 | — |
| GSK Investigational Site | Boston | Massachusetts | 02215 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89102 | — |
| GSK Investigational Site | Newark | New Jersey | 7102 | — |
| GSK Investigational Site | Rochester | New York | 14604 | — |
| GSK Investigational Site | Greenville | South Carolina | 29605 | — |
| GSK Investigational Site | Dallas | Texas | 75246 | — |
| GSK Investigational Site | Houston | Texas | 77027 | — |
| GSK Investigational Site | Hampton | Virginia | 23666 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00242879, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 30, 2017 · Synced Nov 7, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00242879 live on ClinicalTrials.gov.