Clinical trial NCT02456558: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asymptomatic HIV Infection
Keywords: HIV infection
antiretroviral drugs
deferiprone
pharmacokinetics
Lead sponsor: ApoPharma
Sponsor class: INDUSTRY
First posted: 2015-05-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in HIV viral load
timeFrame: Day 1 to Day 56
measure: Change from baseline in CD4+ T-cell count
timeFrame: Day 1 to Day 56
measure: Change from baseline in level of HIV DNA in peripheral blood mononucleated cells
timeFrame: Day 1 to Day 56
measure: Proportion of subjects withdrawn due to the need for rescue medication
timeFrame: Day 1 to Day 56
measure: Number of subjects with adverse events
timeFrame: Day 1 to Day 56
Secondary outcomes:
measure: 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
timeFrame: 10-hour interval
Other outcomes:
Locations:
city: Port Elizabeth
country: South Africa
facility: Phoenix Pharma
state: Eastern Cape
city: Pretoria
country: South Africa
facility: VxPharma
Study officials:
References: