Back to resultsEvaluation of the Safety, Efficacy, and Pharmacokinetics of Intravenous Deferiprone in HIV-Positive Subjects
Primary Purpose
Asymptomatic HIV Infection
Status
Completed
Phase
Phase 1
Locations
South Africa
Study Type
Interventional
Intervention
Intravenous deferiprone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asymptomatic HIV Infection focused on measuring HIV infection, antiretroviral drugs, deferiprone, pharmacokinetics
Eligibility 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
Sites / Locations
- Phoenix Pharma
- VxPharma
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Intravenous deferiprone, 1.5 g
Intravenous deferiprone, 2 g
Placebo
Arm Description
Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 1.5 g, twice-daily
Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 2 g, twice-daily
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
Outcomes
Primary Outcome Measures
Change from baseline in HIV viral load
Change from baseline in CD4+ T-cell count
Change from baseline in level of HIV DNA in peripheral blood mononucleated cells
Proportion of subjects withdrawn due to the need for rescue medication
Number of subjects with adverse events
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02456558
Brief Title
Evaluation of the Safety, Efficacy, and Pharmacokinetics of Intravenous Deferiprone in HIV-Positive Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ApoPharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymptomatic HIV Infection
Keywords
HIV infection, antiretroviral drugs, deferiprone, pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous deferiprone, 1.5 g
Arm Type
Experimental
Arm Description
Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 1.5 g, twice-daily
Arm Title
Intravenous deferiprone, 2 g
Arm Type
Experimental
Arm Description
Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 2 g, twice-daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Intravenous deferiprone
Other Intervention Name(s)
IV DFP, Deferiprone injection, solution
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline solution (0.9% w/v NaCl)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in HIV viral load
Time Frame
Day 1 to Day 56
Title
Change from baseline in CD4+ T-cell count
Time Frame
Day 1 to Day 56
Title
Change from baseline in level of HIV DNA in peripheral blood mononucleated cells
Time Frame
Day 1 to Day 56
Title
Proportion of subjects withdrawn due to the need for rescue medication
Time Frame
Day 1 to Day 56
Title
Number of subjects with adverse events
Time Frame
Day 1 to Day 56
Secondary Outcome Measure Information:
Title
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. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Phoenix Pharma
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6001
Country
South Africa
Facility Name
VxPharma
City
Pretoria
ZIP/Postal Code
0087
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety, Efficacy, and Pharmacokinetics of Intravenous Deferiprone in HIV-Positive Subjects
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