Evaluation of the Safety, Efficacy, and Pharmacokinetics of Intravenous Deferiprone in HIV-Positive Subjects

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.

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

Details

• Lead Sponsor: ApoPharma
• Treatments: Deferiprone; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• HIV-1 positive

• HIV treatment-naïve: no previous treatment with a combination anti-retroviral therapy (cART) or highly active anti-retroviral therapy (HAART) regimen

• HIV-1 RNA > 10,000 copies/mL

• ALT or AST ≤ 2.0 x upper limit of normal range, and bilirubin within normal range

• Body mass index (BMI) of 18.5 to 30.0 kg/m^2

• Absolute neutrophil count at baseline of ≥1.0 x 10^9/L (black African population only) or ≥1.5 x 10^9/L (all other races)

Exclusion Criteria:

• Evidence of AIDS-associated illness, excluding superficial candidiasis

• CD4+ T-cell count of < 350/mm^3

• Positive for active or latent tuberculosis, as determined by the QuantiFERON®-TB Gold test

• Active, serious infections (other than HIV-1 infection) within the 30 days prior to screening

• Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis virus C (HCV) antibodies

• History or presence of malignancy

• A serious, unstable chronic illness during the past 3 months before screening

• A serious, unresolved acute illness at screening