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

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.

Official Title

The Pharmacokinetics and Safety of Ritonavir-Boosted Indinavir 600/100mg Bid Combined With NRTIs in ARV naive HIV/TB co-Infected Patients Receiving Rifampicin Containing Anti-Tuberculosis Therapy

Conditions

• HIV Infections
• Tuberculosis

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Further Details

• Primary Outcomes: pharmacokinetics of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy.
• Secondary Outcomes: safety of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy; efficacy of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy; the prevalence of immune recovery syndrome of TB and other HIV-related conditions after ritonavir-boosted indinavir 600/100mg bid

Study Start

December 2006; Expected completion: June 2008

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 60 Years
• Genders Eligible for Study: Both

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%

  Total Enrolment

  20 (expected)

  Contact Details

  • Anchalee Avihingsanon, MD +66 2 2557334-5 Ext. 107 anchalee.a@hivnat.org
  • Kiat Ruxrungtham, MD + 66 2 2557334-5 rkiat@chula.ac.th

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