Status:
COMPLETED
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
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
Ministry of Health, Thailand
Conditions:
HIV Infections
Tuberculosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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.
Detailed Description
Fixed dose combination of d4T+3TC+NVP (GPOvir) is widely used in Thai HIV infected since June 2002. The prevalence of NNRTI resistance has increased since 2005. Tuberculosis can develop following NNRT...
Eligibility Criteria
Inclusion
- Confirmed HIV positive after voluntary counseling and testing
- Aged \>18-60years of age
- ARV naïve and NNRTI failure ( PI naive)
- CD4+ cell count of \<350 cells/mm3 at the time of diagnosed TB
- ALT \<5 times ULN
- Serum creatinine \<1.4 mg/dl
- Hemoglobin \>8 mg/L
- TB is diagnosed and planned to receive stable doses of rifampicin-containing anti-TB therapy for at least a 2 week period after initiation of ART
- No other active OI (CDC class C event), except oral candidiasis or disseminated MAC
- Able to provide written informed consent
Exclusion
- Current use of steroid (except short course steroid for IRIS) and other immunosuppressive agents.
- Current use of any prohibited medications related to drug pharmacokinetics.
- Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial.
- Unlikely to be able to remain in follow-up for the protocol defined period.
- Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST \< 5 x ULN.
- Karnofsky performance score \<30%
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01138202
Start Date
November 1 2010
End Date
December 1 2015
Last Update
July 17 2020
Active Locations (1)
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1
HIV-NAT Thai Red Cross AIDS Research Center
Bangkok, Thailand, 10330