Status:
TERMINATED
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
Lead Sponsor:
ViiV Healthcare
Conditions:
Infection, Human Immunodeficiency Virus I
HIV-1 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 thera...
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 P...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00242879
Start Date
August 1 2005
End Date
June 1 2007
Last Update
May 30 2017
Active Locations (70)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85006
2
GSK Investigational Site
Bakersfield, California, United States, 93301
3
GSK Investigational Site
Fountain Valley, California, United States, 92708
4
GSK Investigational Site
Los Angeles, California, United States, 90046