Asymptomatic HIV InfectionPhase 1NCT02456558
Evaluation of the Safety, Efficacy, and Pharmacokinetics of Intravenous Deferiprone in HIV-Positive Subjects
A Phase 1 study testing Intravenous deferiprone in people with Asymptomatic HIV Infection, run by ApoPharma at 2 sites in South Africa.
Trial summary
This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asymptomatic HIV Infection
- What is being tested?
- Intravenous deferiprone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Jun 2015to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Phoenix Pharma
Port Elizabeth, Eastern Cape, 6001
VxPharma
Pretoria, 0087
About this study
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
This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.
Read the 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.
- Conditions
- Asymptomatic HIV Infection
- Being tested
- Intravenous deferiprone, Placebo
- Keywords
- HIV infection, antiretroviral drugs, deferiprone, pharmacokinetics
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous deferiproneDrug
Also called IV DFP, Deferiprone injection, solution
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.
PlaceboDrug
Also called Normal saline solution (0.9% w/v NaCl)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HIV viral load
Measured: Day 1 to Day 56
Change from baseline in CD4+ T-cell count
Measured: Day 1 to Day 56
Change from baseline in level of HIV DNA in peripheral blood mononucleated cells
Measured: Day 1 to Day 56
Proportion of subjects withdrawn due to the need for rescue medication
Measured: Day 1 to Day 56
Number of subjects with adverse events
Measured: 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
Measured: 10-hour interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ApoPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456558
- Sponsor's protocol ID
- LA44-0114
- Status last verified
- Jun 2016
- First submitted
- 26 May 2015
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02456558
- Acronym / sponsor ID
- LA44-0114
- Conditions
- Asymptomatic HIV Infection
- Keywords
- HIV infection, antiretroviral drugs, deferiprone, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ApoPharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous deferiprone, 1.5 g | Experimental | Drug: Intravenous deferiproneSubjects in this arm will receive an infusion of intravenous deferiprone at a dose of 1.5 g, twice-daily |
| Intravenous deferiprone, 2 g | Experimental | Drug: Intravenous deferiproneSubjects in this arm will receive an infusion of intravenous deferiprone at a dose of 2 g, twice-daily |
| Placebo | Placebo comparator | Drug: PlaceboSubjects 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous deferiproneAlso: IV DFP, Deferiprone injection, solutionIn 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. | Drug | Intravenous deferiprone, 1.5 g, Intravenous deferiprone, 2 g |
| PlaceboAlso: Normal saline solution (0.9% w/v NaCl)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. | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
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Questioning the Epidemiology of Asymptomatic TB
Tuberculosis, Tuberculosis (TB)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous deferiprone in people with Asymptomatic HIV Infection, run by ApoPharma at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HIV viral load (time frame: Day 1 to Day 56). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2016.