NCT02456558

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 7, 2016

Status Verified

June 1, 2016

Enrollment Period

9 months

First QC Date

May 26, 2015

Last Update Submit

June 3, 2016

Conditions

Asymptomatic HIV Infection

Keywords

HIV infectionantiretroviral drugsdeferipronepharmacokinetics

Outcome Measures

Primary Outcomes (5)

  • Change from baseline in HIV viral load

    Day 1 to Day 56

  • Change from baseline in CD4+ T-cell count

    Day 1 to Day 56

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

    Day 1 to Day 56

  • Proportion of subjects withdrawn due to the need for rescue medication

    Day 1 to Day 56

  • Number of subjects with adverse events

    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

    10-hour interval

Study Arms (3)

Intravenous deferiprone, 1.5 g

EXPERIMENTAL

Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 1.5 g, twice-daily

Drug: Intravenous deferiprone

Intravenous deferiprone, 2 g

EXPERIMENTAL

Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 2 g, twice-daily

Drug: Intravenous deferiprone

Placebo

PLACEBO COMPARATOR

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

Interventions

Intravenous deferiproneDRUG

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.

Also known as: IV DFP, Deferiprone injection, solution
Intravenous deferiprone, 1.5 gIntravenous deferiprone, 2 g
PlaceboDRUG

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.

Also known as: Normal saline solution (0.9% w/v NaCl)
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Phoenix Pharma

Port Elizabeth, Eastern Cape, 6001, South Africa

Location

VxPharma

Pretoria, 0087, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Interventions

IsoflurophateDeferiproneSolutions

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganofluorophosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridonesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

May 28, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

June 7, 2016

Record last verified: 2016-06

Locations

ZA(2)