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Completed

NCT Number: NCT02456558

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

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

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Key information

Conditions

Asymptomatic HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phoenix Pharma, Port Elizabeth, Eastern Cape, South Africa

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About this study

This is a double-blind, placebo-controlled, randomized trial in 30 asymptomatic HIV-positive adults. There are two sequential cohorts, in which subjects will receive either one of 2 doses of deferiprone or placebo twice daily.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous deferiprone

Drug

In Cohort 1, the subjects who were randomized to get active product will receive deferiprone at a dose of 1.5 g per infusion, and if there are no significant safety concerns, the subjects in Cohort 2 who were randomized to get active product will receive it a a dose of 2 g per infusion.

Other names: IV DFP, Deferiprone injection, solution

Placebo

Drug

In both cohorts, the subjects who were randomized to get placebo will receive an infusion of placebo solution that is equal in volume to that of the active product.

Other names: Normal saline solution (0.9% w/v NaCl)

Primary outcomes

  1. Change from baseline in HIV viral load

    Time frame: Day 1 to Day 56

  2. Change from baseline in CD4+ T-cell count

    Time frame: Day 1 to Day 56

  3. Change from baseline in level of HIV DNA in peripheral blood mononucleated cells

    Time frame: Day 1 to Day 56

  4. Proportion of subjects withdrawn due to the need for rescue medication

    Time frame: Day 1 to Day 56

  5. Number of subjects with adverse events

    Time frame: Day 1 to Day 56

Secondary outcomes

  1. The pharmacokinetics parameters of Cmax, Tmax, and AUC0-∞, and T1/2 for deferiprone will be determined pre-dose and at specified time points post-dose

    Time frame: 10-hour interval

Sponsors and collaborators

Lead sponsor

ApoPharma

Industry

Registry information

Official study title

A Phase Ib Randomized, Double-blind, Placebo-controlled, Ascending Sequential Dose, Adaptive Design Study to Evaluate the Safety, Antiretroviral Activity, and Pharmacokinetics of Intravenous Deferiprone in Treatment-Naïve HIV-Positive Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 28, 2015
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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