Human Immunodeficiency Virus InfectionsPhase 2NCT02452242
Safety, PK and PD Study of ABX464 in Untreated HIV Patients
A Phase 2 study testing ABX464 in people with Human Immunodeficiency Virus Infections, run by Abivax S.A. at 4 sites in 2 countries.
Trial summary
ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is intended to assess the safety, the tolerability, and pharmacokinetic parameters and to evaluate the effect on viral load of repeated oral administrations of ABX464 in patients infected by HIV, not previously treated for their… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Human Immunodeficiency Virus Infections
- What is being tested?
- ABX464
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2015to May 2016
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, 18 to 65 years of age
- Patients infected by HIV-1 or HIV-2
- BMI between 17 and 29 kg/m².
- CD4 cell count ≥ 350 /mm3 and HIV RNA level between 5,000-500,000 copies/mL.
- Clinical laboratory tests (hematology, blood chemistry, and urinalyses) must be within normal limits, or clinically acceptable to the sponsor and principal investigator and consistent with the underlying HIV infection.
- Urine drug screen for drugs with a high potential for abuse (cocaine, opiates, amphetamines and barbiturates) and alcohol breath test must be negative.
Show all 11Show fewer
- Females must be non lactating and either be of nonchildbearing potential (ie sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal) or if of child bearing potential, must be practicing effective double barrier contraceptive methods from at least two weeks prior to Day 1 until 3 months after the last dose of study medication.
- Males must practice an effective barrier method of contraception from Day 1 until 3 months days after the last dose of study medication.
- Patients must be willing to give written informed consent prior to study enrollment and be able to adhere to restrictions and examination schedules.
- Physical examination and ECG must be within normal limits.
- Never taken any antiretroviral agent except for a brief time, and for some reasons, the patient decided not to continue therapy (i.e. Toxicity, personal decision. None in past 30-180 days.
Who cannot join
- Individuals with a history of any significant medical disorders which requires a physician's care.
- Individuals who have a history of any clinically significant local or systemic infectious disease (other than HIV-1 or HIV-2 infection) within four weeks prior to drug administration.
- Individuals with any clinically significant laboratory abnormalities as defined as grade 2 or 3 in Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
- Individuals who are positive for hepatitis B virus and/or hepatitis C virus
- Any individual who does not comply with the requirement that he should not have used any drugs (including prescription, nonprescription, herbal, and mineral supplements) other than paracetamol for at least two weeks prior to the study nor alcohol within 48 hours prior to drug administration and for the entire study period. The use of a concomitant medications to treat an AE during the study will not be considered a protocol violation.
- Individuals who have participated in a clinical trial of an investigational drug within 90 days prior to the start of the study
- Individuals who smoke more than ten cigarettes or equivalent tobacco use per day.
- Individuals with forfeiture of freedom by an administrative or legal obligation or under guardianship
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Thailand3 sites
HIV-NAT, Thai Red Cross AIDS Research Center
Bangkok, 10330
Siriraj Hospital, Mahidol University
Bangkok, 10700
Chiang Mai University
Chiang Mai, 50200
About this study
Official title: A Phase 2, Dose Escalation, Schedule Comparison Study to Evaluate the Safety, Pharmacokinetics, and Viral Kinetics of ABX464 in Untreated Patients With HIV Infection in Mauritius
ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is intended to assess the safety, the tolerability, and pharmacokinetic parameters and to evaluate the effect on viral load of repeated oral administrations of ABX464 in patients infected by HIV, not previously treated for their HIV.
Two types of design are intended in this protocol: dosing every 3 days or dosing every day. The goal is to determine the best dosing regimen to reduce viral load and minimize adverse events.
- Conditions
- Human Immunodeficiency Virus Infections
- Being tested
- ABX464, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX464Drug
25, 50, 75, 100, 150 mg, i.e. 1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks
PlaceboOther
1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| ABX464 | Experimental | Not described Receives: Drug: ABX464 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability profile of ABX464 as assessed by the change from baseline in laboratory values, in vital signs and ECG parameters at week 3 and by the number of patients with adverse events.
Number of patients with abnormal blood (hematology and biochemistry) and urinary laboratory values, abnormal vital signs and ECG parameters and the number/proportion of patients reporting any adverse event.
Measured: Week 3
Secondary outcomes (6)
Cmax
Maximum concentration in plasma of ABX464 and metabolite
Measured: week 1, week 2 and week 3
tmax
Time to maximum concentration
Measured: Week 3
AUC
Area under the concentration-time curve
Measured: Week 3
t1/2
Half-life of the ABX464 in plasma
Measured: Week 3
Pharmacodynamic activity as expressed by CD4 and CD8 count
CD4 and CD8 values
Measured: Week 3
Pharmacodynamic activity as expressed by HIV viral load
HIV viral load across time and possible relationship with PK parameters
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus InfectionsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abivax S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452242
- Sponsor's protocol ID
- ABX464-003
- Status last verified
- May 2015
- First submitted
- 10 Apr 2015
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Steens JM, Scherrer D, Gineste P, Barrett PN, Khuanchai S, Winai R, Ruxrungtham K, Tazi J, Murphy R, Ehrlich H. Safety, Pharmacokinetics, and Antiviral Activity of a Novel HIV Antiviral, ABX464, in Treatment-Naive HIV-Infected Subjects in a Phase 2 Randomized, Controlled Study. Antimicrob Agents Chemother. 2017 Jun 27;61(7):e00545-17. doi: 10.1128/AAC.00545-17. Print 2017 Jul.
PubMed 28507108
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Dose Escalation, Schedule Comparison Study to Evaluate the Safety, Pharmacokinetics, and Viral Kinetics of ABX464 in Untreated Patients With HIV Infection in Mauritius
- ClinicalTrials.gov ID
- NCT02452242
- Acronym / sponsor ID
- ABX464-003
- Conditions
- Human Immunodeficiency Virus Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Abivax S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 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.
ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is intended to assess the safety, the tolerability, and pharmacokinetic parameters and to evaluate the effect on viral load of repeated oral administrations of ABX464 in patients infected by HIV, not previously treated for their HIV.
Two types of design are intended in this protocol: dosing every 3 days or dosing every day. The goal is to determine the best dosing regimen to reduce viral load and minimize adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABX464 | Experimental | Drug: ABX464 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males or females, 18 to 65 years of age
- Patients infected by HIV-1 or HIV-2
- BMI between 17 and 29 kg/m².
- CD4 cell count ≥ 350 /mm3 and HIV RNA level between 5,000-500,000 copies/mL.
- Clinical laboratory tests (hematology, blood chemistry, and urinalyses) must be within normal limits, or clinically acceptable to the sponsor and principal investigator and consistent with the underlying HIV infection.
Key exclusion criteria (8 listed)
- Individuals with a history of any significant medical disorders which requires a physician's care.
- Individuals who have a history of any clinically significant local or systemic infectious disease (other than HIV-1 or HIV-2 infection) within four weeks prior to drug administration.
- Individuals with any clinically significant laboratory abnormalities as defined as grade 2 or 3 in Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
- Individuals who are positive for hepatitis B virus and/or hepatitis C virus
- Any individual who does not comply with the requirement that he should not have used any drugs (including prescription, nonprescription, herbal, and mineral supplements) other than paracetamol for at least two weeks prior to the study nor alcohol within 48 hours prior to drug administration and for the entire study period. The use of a concomitant medications to treat an AE during the study will not be considered a protocol violation.
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 |
|---|---|---|
| ABX46425, 50, 75, 100, 150 mg, i.e. 1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks | Drug | ABX464 |
| Placebo1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks | Other | Placebo |
Primary outcome
Safety and tolerability profile of ABX464 as assessed by the change from baseline in laboratory values, in vital signs and ECG parameters at week 3 and by the number of patients with adverse events.
Time frame: Week 3
Number of patients with abnormal blood (hematology and biochemistry) and urinary laboratory values, abnormal vital signs and ECG parameters and the number/proportion of patients reporting any adverse event.
6 secondary outcomes
Cmax
Time frame: week 1, week 2 and week 3
tmax
Time frame: Week 3
AUC
Time frame: Week 3
t1/2
Time frame: Week 3
Pharmacodynamic activity as expressed by CD4 and CD8 count
Time frame: Week 3
Pharmacodynamic activity as expressed by HIV viral load
Time frame: Week 3
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 30 May 2016.
- Derived from this study: PubMed 28507108Steens JM, Scherrer D, Gineste P, Barrett PN, Khuanchai S, Winai R, Ruxrungtham K, Tazi J, Murphy R, Ehrlich H. Safety, Pharmacokinetics, and Antiviral Activity of a Novel HIV Antiviral, ABX464, in Treatment-Naive HIV-Infected Subjects in a Phase 2 Randomized, Controlled Study. Antimicrob Agents Chemother. 2017 Jun 27;61(7):e00545-17. doi: 10.1128/AAC.00545-17. Print 2017 Jul.
Related trials for Human Immunodeficiency Virus Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABX464 in people with Human Immunodeficiency Virus Infections, run by Abivax S.A. at 4 sites in 2 countries.
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 11 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 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand, Mauritius. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and tolerability profile of ABX464 as assessed by the change from baseline in laboratory values, in vital signs and ECG parameters at week 3 and by the number of patients with adverse events. (time frame: Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02452242, which also lists 1 linked publication.
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 30 May 2016.