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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborator: Department of Disease Control, Ministry of Public Health Thailand
• Treatments: Antitubercular Agents; Lopinavir; Reverse Transcriptase Inhibitors; Rifampin; Ritonavir

Criteria

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%