Status:
COMPLETED
The Pharmacokinetics and Safety of IDV/r With NRTIs in HIV/TB Co-infected Patients Receiving Rifampicin
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Conditions:
HIV Infections
Tuberculosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
We believe that there is a strong rationale for the study of IDV/r 600/100 bid as a boosted-PI combination that, in the presence of RMP, is able to produce a satisfactory PK profile associated with ad...
Detailed Description
The fixed-dose combination of d4T+3TC+NVP (GPOvir) has been widely used in Thailand since June 2002. The prevalence of NNRTI resistance has increased since 2005. Efavirenz-based antiretroviral therapy...
Eligibility Criteria
Inclusion
- Confirmed HIV positive after voluntary counselling and testing
- Aged between 18 and 60 years of age
- Antiretroviral treatment naive
- CD4+ cell count of \<200 cells/mm3 at the time of TB diagnosis
- ALT \<5 times ULN
- Serum creatinine \<1.4 mg/dl
- Haemoglobin \>8 mg/L
- TB diagnosis; either probable (clinical symptoms plus chest x-ray and response to anti-TB medication) or definitive( sputum AFB culture confirmed) and receiving or planning to receive rifampicin-containing anti-TB therapy for at least a 2 week period before the initiation of ART
- No other active OI (CDC class C event)
- Able to provide written informed consent
Exclusion
- Current use of steroids and other immunosuppressive agents
- Current use of any prohibited medications related to compliance and 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.
- Previous exposure to nevirapine monotherapy
- 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 :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00411996
Start Date
December 1 2006
End Date
December 1 2009
Last Update
July 17 2020
Active Locations (1)
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1
HIV-NAT Thai Red Cross AIDS Research Center
Bangkok, Thailand, 10330