Status:
COMPLETED
Second-line Therapy Antiretroviral in Patients Who Failed Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) - Based Regimens
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
National Health Security Office, Thailand
Swiss HIV Cohort Study
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy and safety at 48 weeks between LPV/r monotherapy and 2 NRTIs + LPV/r therapy in patients failing a standard NNRTI-based treatment regimen. Also, to evaluate the short-term 24-...
Detailed Description
With at least 80,000 HIV-1 infected individuals throughout Thailand currently on generically produced fixed dose combination of d4T/3TC/NVP or GPOvir as a first line national recommendation therapy, w...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- HIV seropositive.
- Have had NNRTI-based HAART in the past for at least 6 months
- Naïve to protease inhibitors (PIs)
- Plasma HIVRNA ≥ 1000 copies/ml
- Signed written informed consent
Exclusion
- Active AIDS-defining disease or active opportunistic infection
- Previously treated with PIs
- Pregnancy (negative pregnancy test for women of childbearing potential at screening).
- Documented chronic hepatitis B (HbsAg positive)
- ALT ≥ 200 U/L
- Creatinine clearance \< 60 c.c. per min by Cockroft-Gault formula formula
- Use of medication that interfere with the action of LPV/r
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00627055
Start Date
May 1 2008
End Date
November 1 2010
Last Update
July 17 2020
Active Locations (10)
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1
Chonburi Hospital
Chon Buri, Changwat Chon Buri, Thailand
2
Chulalongkorn University
Bangkok, Thailand, 10330
3
Hivnat, Trcarc
Bangkok, Thailand, 10330
4
Siriraj Hospital
Bangkok, Thailand, 10700