The Pharmacokinetics and Safety of IDV/r With NRTIs in HIV/TB Co-infected Patients Receiving Rifampicin

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 adequate antiretroviral potency, tolerability and efficacy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Treatments: Indinavir; Rifampin; Ritonavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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%