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

Stopped early · Phase 2

Conditions studied: Infection, Human Immunodeficiency Virus I, HIV-1 Infection

In brief

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.

Key facts

Study ID

NCT00242879

Run by

ViiV Healthcare

People needed

130

Starts

2005-08-01

Expected to finish

2007-06-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Bakersfield, California, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Norwalk, Connecticut, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Bradenton, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Miami Beach, Florida, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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