HIV Infections Clinical Trial
Official title:
A Pilot Study of the Pharmacokinetics and Safety of Lopinavir/Ritonavir 400/100mg Bid Versus Lopinavir/Ritonavir 600/150 mg BID Combined With Nucleoside Analogue Reverse Transcriptase Inhibitors in HIV/TB Co-infected Patients Receiving Rifampicin Containing Anti-tuberculosis Therapy
Verified date | July 2020 |
Source | The HIV Netherlands Australia Thailand Research Collaboration |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Confirmed HIV positive after voluntary counseling and testing 2. Aged >18-60years of age 3. ARV naïve and NNRTI failure ( PI naive) 4. CD4+ cell count of <350 cells/mm3 at the time of diagnosed TB 5. ALT <5 times ULN 6. Serum creatinine <1.4 mg/dl 7. Hemoglobin >8 mg/L 8. 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 9. No other active OI (CDC class C event), except oral candidiasis or disseminated MAC 10. Able to provide written informed consent Exclusion Criteria: 1. Current use of steroid (except short course steroid for IRIS) and other immunosuppressive agents. 2. Current use of any prohibited medications related to drug pharmacokinetics. 3. 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. 4. Unlikely to be able to remain in follow-up for the protocol defined period. 5. Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST < 5 x ULN. 6. Karnofsky performance score <30% |
Country | Name | City | State |
---|---|---|---|
Thailand | HIV-NAT Thai Red Cross AIDS Research Center | Bangkok |
Lead Sponsor | Collaborator |
---|---|
The HIV Netherlands Australia Thailand Research Collaboration | Department of Disease Control, Ministry of Public Health Thailand |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | plasma concentration level | Percentage of plasma concentration level above an acceptable lower limit (lopinavir Cmin > 1 mg/L) at steady-state. | 12 hours | |
Secondary | identify toxicities | Toxicity of combined treatment for TB and HIV infections - the established DAIDS/ACTG toxicity grading scale of clinical and laboratory toxicities will be used. | 48 weeks | |
Secondary | CD4 | CD4 response (mean CD4 rise from baseline) | 48 weeks | |
Secondary | HIV RNA | HIV RNA response (% < 50 copies/ml at week 12, 24 and 48) | 48 weeks | |
Secondary | genotypic resistant | The emergence of NRTI and/or lopinavir genotypic resistant and its clinically | 48 weeks |
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