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

Asymptomatic HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456558
• Other study ID #: LA44-0114
• Status: Completed
• Phase: Phase 1
• First received: May 26, 2015
• Last updated: June 3, 2016
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: ApoPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asymptomatic HIV Infection
• HIV Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
South Africa	Phoenix Pharma	Port Elizabeth	Eastern Cape
South Africa	VxPharma	Pretoria

Sponsors (1)

Lead Sponsor	Collaborator
ApoPharma

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HIV viral load		Day 1 to Day 56	No
Primary	Change from baseline in CD4+ T-cell count		Day 1 to Day 56	No
Primary	Change from baseline in level of HIV DNA in peripheral blood mononucleated cells		Day 1 to Day 56	No
Primary	Proportion of subjects withdrawn due to the need for rescue medication		Day 1 to Day 56	No
Primary	Number of subjects with adverse events		Day 1 to Day 56	Yes
Secondary	The pharmacokinetics parameters of Cmax, Tmax, and AUC0-8, and T1/2 for deferiprone will be determined pre-dose and at specified time points post-dose		10-hour interval	No