Pharmacokinetics (PK) and Safety of 2 Different Doses of Lopinavir/Ritonavir in in HIV/Tuberculosis (TB) Co-infected Patients Receiving Rifampicin Containing Anti-tuberculosis Therapy
NCT01138202 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2020-07-17
Summary
To assess safety, efficacy and impact of Lopinavir/ritonavir 400/100mg bid or Lopinavir/ritonavir 600/150mg bid in combination with rifampicin-containing anti-TB therapy.
Conditions
- HIV Infections
- Tuberculosis
Interventions
- DRUG
-
LPV/r
LPV/r 400/100 mg BID + 2 NRTI for arm 1 (total 48 weeks) LPV/r 600/150 mg BID + 2 NRTI for arm 2 (total 48 weeks)
Sponsors & Collaborators
-
Ministry of Health, Thailand
collaborator OTHER_GOV -
The HIV Netherlands Australia Thailand Research Collaboration
lead OTHER
Principal Investigators
-
Anchalee Avihingsanon, MD · The HIV Netherlands Australia Thailand Research Collaboration
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- Thailand
Study Locations
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