Tenofovir Pharmacokinetics in HIV-infected Thai Adults With Moderate Renal Function Impairment Receiving Either a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Based or Lopinavir/Ritonavir-based Antiretroviral Therapy (ALTER)

NCT01671982 Phase 1 COMPLETED

To assess the drug concentrations of tenofovir (TDF) in HIV-infected Thai adults with moderate renal function impairment when administered at the recommended dose of 300 mg every 48 hours, and at an alternative dose of 150 mg every 24 hours.

Details

Lead sponsor	Institut de Recherche pour le Developpement
Phase	Phase 1
Status	COMPLETED
Enrolment	40
Start date	2012-08
Completion	2015-05

Conditions

• HIV

Interventions

• Tenofovir Dose Adjustment

Primary outcomes

• Tenofovir plasma area-under the concentration time curve (AUC) — Study Entry and Day 14
  For each patient, ratios of AUC0-last of q24h versus q48h will be calculated. Geometric mean ratios (GMRs) with 90% CI will be calculated after log-transformation of within patient ratios.

Countries

Thailand