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

June 3, 2016 updated by: ApoPharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Pretoria, South Africa, 0087
        • VxPharma
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6001
        • Phoenix Pharma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravenous deferiprone, 1.5 g
Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 1.5 g, twice-daily
Drug: Intravenous deferiprone
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
Experimental: Intravenous deferiprone, 2 g
Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 2 g, twice-daily
Drug: Intravenous deferiprone
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 Comparator: Placebo
Subjects in this arm will receive an infusion of placebo twice-daily for 10 days, at a volume equivalent to that of the active product in the respective cohort
Drug: Placebo
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HIV viral load
Time Frame: Day 1 to Day 56
Day 1 to Day 56
Change from baseline in CD4+ T-cell count
Time Frame: Day 1 to Day 56
Day 1 to Day 56
Change from baseline in level of HIV DNA in peripheral blood mononucleated cells
Time Frame: Day 1 to Day 56
Day 1 to Day 56
Proportion of subjects withdrawn due to the need for rescue medication
Time Frame: Day 1 to Day 56
Day 1 to Day 56
Number of subjects with adverse events
Time Frame: Day 1 to Day 56
Day 1 to Day 56

Secondary Outcome Measures

Outcome Measure
Time Frame
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
10-hour interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ApoPharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Estimate)

June 7, 2016

Last Update Submitted That Met QC Criteria

June 3, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LA44-0114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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