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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ApoPharma
ClinicalTrials.gov Identifier:
NCT02456558
First received: May 26, 2015
Last updated: June 3, 2016
Last verified: June 2016
  Purpose
This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.

Condition Intervention Phase
Asymptomatic HIV Infection Drug: Intravenous deferiprone Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by ApoPharma:

Primary Outcome Measures:
  • Change from baseline in HIV viral load [ Time Frame: Day 1 to Day 56 ]
  • Change from baseline in CD4+ T-cell count [ Time Frame: 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 ]
  • Proportion of subjects withdrawn due to the need for rescue medication [ Time Frame: Day 1 to Day 56 ]
  • Number of subjects with adverse events [ Time Frame: Day 1 to Day 56 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: June 2015
Study Completion Date: May 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Normal saline solution (0.9% w/v NaCl)

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02456558

Locations
South Africa
Phoenix Pharma
Port Elizabeth, Eastern Cape, South Africa, 6001
VxPharma
Pretoria, South Africa, 0087
Sponsors and Collaborators
ApoPharma
  More Information

Responsible Party: ApoPharma
ClinicalTrials.gov Identifier: NCT02456558     History of Changes
Other Study ID Numbers: LA44-0114
Study First Received: May 26, 2015
Last Updated: June 3, 2016

Keywords provided by ApoPharma:
HIV infection
antiretroviral drugs
deferiprone
pharmacokinetics

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Pharmaceutical Solutions
Deferiprone
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 25, 2017