HIVPhase 1NCT02631473
PK of Efavirenz & Lopinavir Nano-formulations in Healthy Volunteers
A Phase 1 study testing 50mg NANO-efavirenz, 400mg NANO-Lopinavir and 200mg NANO-Lopinavir in people with HIV, run by St Stephens Aids Trust at 1 site in United Kingdom.
Trial summary
This study is an open-label, prospective pharmacokinetic study investigating two antiretroviral agents in parallel and employing an adaptive design with two stages, whereby the results obtained in the primary stage inform the doses selected for investigation in the secondary stage Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- 50mg NANO-efavirenz, 400mg NANO-Lopinavir and 200mg NANO-Lopinavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to Nov 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers must meet all of the following inclusion criteria within 28 days prior to the baseline visit:
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
- Male or non-pregnant, non-lactating females
- Between 18 to 65 years, inclusive
- Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 12 weeks after the study
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- A female may be eligible to enter and participate in the study if she:
- is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
- is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy:
- Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications;
- Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide);
- Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion, see protocol appendix 7 for an example listing of approved IUDs);
- Condom and depot medroxyprogesterone acetate ( DMPA) injections
- Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject;
- Any other method with published data showing that the expected failure rate is <1% per year.
- Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of IP.
- Willing to consent to their personal details being entered onto the TOPS database
- Willing to provide proof of identity by photographic ID at screen and any subsequent visit
- Registered with a GP in the UK
Who cannot join
- Volunteers who meet any of the following exclusion criteria are not to be enrolled in this study.
- Any significant acute or chronic medical illness including hypertension (BP persistently >140/90 mmHg) or hypotension (BP persistently <90/60 mmHg)
- Prolongation of ECG intervals: PR > 200 msec or QTcF > 450 msec.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations.
- Liver transaminase (ALT or AST > 1.25 x the upper limit of the normal range)
- Significant psychiatric history (including severe depression) or history of seizures.
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- Positive blood screen for either hepatitis B surface antigen or hepatitis C antibody
- Positive blood screen for HIV-1 and/or 2 antibodies
- Current or recent (within 3 months) gastrointestinal disease
- Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder adherence to treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
- Known cardiac disease history of any family history of sudden cardiac death.
- Exposure to any investigational drug or placebo within 3 months of first dose of study drug
- Use of any other drugs (unless approved by the Investigator), including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs.
- Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 12 weeks after the end of the treatment period
- Previous allergy to any of the constituents of the pharmaceuticals administered in this trial
- Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Efavirenz and Lopinavir Nano-formulations in HIV Negative Healthy Volunteers: an Adaptive Design Study
This study is an open-label, prospective pharmacokinetic study investigating two antiretroviral agents in parallel and employing an adaptive design with two stages, whereby the results obtained in the primary stage inform the doses selected for investigation in the secondary stage
Read the detailed description
The objectives of this study are:
Primary
- To investigate the pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANO-efavirenz) in HIV negative healthy volunteers after single dose and a steady-state.
- To investigate the pharmacokinetics of a new pharmaceutical formulation of lopinavir (NANO-lopinavir) in HIV negative healthy volunteers
Secondary
- To investigate the safety and tolerability of NANO-efavirenz and NANO-lopinavir in HIV negative healthy volunteers
- To assess the bioequivalence of a selected single-dose of NANO-efavirenz to a single dose 600mg of efavirenz as Sustiva®
- To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure
- Conditions
- HIV
- Being tested
- 50mg NANO-efavirenz, 400mg NANO-Lopinavir, 200mg NANO-Lopinavir, 100mg Ritonavir, 300mg NANO-Efavirenz
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50mg NANO-efavirenzDrug
OD
400mg NANO-LopinavirDrug
BID
200mg NANO-LopinavirDrug
Also called Efavirenz
BID
100mg RitonavirDrug
Also called Norvir
BID
300mg NANO-EfavirenzDrug
OD
600mg SustivaDrug
Also called Efavirenz
OD
200mg NANO-EfavirenzDrug
OD
Kaletra® (lopinavir 400mg/ritonavir 100mg)Drug
Also called Lopinavir/Ritonavir
BID
+/- 200mg NANO-LopinavirDrug
BID
+/- 200mg ritonavir NORVIRDrug
Also called Ritonavir
BID
400mg SustivaDrug
Also called Efavirenz
| Study group | Role | What they receive |
|---|---|---|
| 1st Stage-Group A | Active comparator | 1. Day 1: 50 mg NANO-efavirenz single dose
2. Days 4-21: 50 mg NANO-efavirenz OD (once daily) Receives: Drug: 50mg NANO-efavirenz |
| 1st Stage-Group B | Active comparator | 1. Days 1-7: 400mg NANO-lopinavir BID (twice daily)
2. Days 8-21: Wash-out period
3. Days: 22-28: 200mg NANO-lopinavir BID plus 100mg Ritonavir (Norvir) BID Receives: Drug: 400mg NANO-Lopinavir; Drug: 200mg NANO-Lopinavir; Drug: 100mg Ritonavir |
| 2nd Stage-Group A-Group 1-Dose level 1 | Active comparator | 1. 21 Days: 300mg NANO-efavirenz OD
2. 4 weeks: Wash-out period
3. 21 days: 600mg Sustiva OD Receives: Drug: 300mg NANO-Efavirenz; Drug: 600mg Sustiva |
| 2nd Stage-Group A-Group 2-Dose level 2 | Active comparator | 1. 21 Days: 200mg NANO-efavirenz OD
2. 4 weeks: Wash-out period
3. 21 days: 400mg Sustiva OD Receives: Drug: 200mg NANO-Efavirenz; Drug: 400mg Sustiva |
| 2nd Stage-Group B-Arm 1 | Active comparator | 1. 7 days: Kaletra® (lopinavir400mg/ritonavir100mg) BD
2. 2 weeks: Wash-out period
3. 7 days: NANO-lopinavir (200mg +/- ritonavir®) Receives: Drug: Kaletra® (lopinavir 400mg/ritonavir 100mg); Drug: +/- 200mg NANO-Lopinavir; Drug: +/- 200mg ritonavir NORVIR |
| 2nd Stage-Group B-Arm 2 | Active comparator | 1. 7 days: NANO-lopinavir (200mg +/- ritonavir Norvir)
2. 2 weeks: Wash-out period
3. 7 days: Kaletra® (lopinavir400mg/ritonavir100mg) BD Receives: Drug: Kaletra® (lopinavir 400mg/ritonavir 100mg); Drug: +/- 200mg NANO-Lopinavir; Drug: +/- 200mg ritonavir NORVIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANOefavirenz) and lopinavir (NANOlopinavir) in HIV negative healthy volunteers, as measured by Ctrough
Trough concentration (Ctrough) is defined as the concentration at 24 hours after the observed drug dose.
Measured: Assessed from baseline visit (day 1) to : 1) Day 31 (Primary Stage Group A); 2) Day 30 (Primary Stage Group B); 3) Day 80 (Secondary Stage Group A); 4) Day 30 (Secondary Stage Group B)
The pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANOefavirenz) and lopinavir (NANOlopinavir) in HIV negative healthy volunteers, as measured by Cmax
Cmax is defined as the maximum observed plasma concentration
Measured: Assessed from baseline visit (day 1) to : 1) Day 31 (Primary Stage Group A); 2) Day 30 (Primary Stage Group B); 3) Day 80 (Secondary Stage Group A); 4) Day 30 (Secondary Stage Group B)
The pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANOefavirenz) and lopinavir (NANOlopinavir) in HIV negative healthy volunteers, as measured by t1/2
t1/2 is defined as the elimination half-life
Measured: Assessed from baseline visit (day 1) to : 1) Day 31 (Primary Stage Group A); 2) Day 30 (Primary Stage Group B); 3) Day 80 (Secondary Stage Group A); 4) Day 30 (Secondary Stage Group B)
The pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANOefavirenz) and lopinavir (NANOlopinavir) in HIV negative healthy volunteers, as measured by Tmax
Tmax is defined as the time point at Cmax (Tmax)
Measured: Assessed from baseline visit (day 1) to : 1) Day 31 (Primary Stage Group A); 2) Day 30 (Primary Stage Group B); 3) Day 80 (Secondary Stage Group A); 4) Day 30 (Secondary Stage Group B)
The pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANOefavirenz) and lopinavir (NANOlopinavir) in HIV negative healthy volunteers, as measured by total drug exposure
Total drug exposure will be expressed as the area under the plasma concentration-time curve (AUC): from 0-12 (AUC0-12h) and 0-56 hours (AUC0-56h) for lopinavir; or 0-24 (AUC0-24h) and 0-228 hours (AUC0-24h) for efavirenz.
Measured: Assessed from baseline visit (day 1) to : 1) Day 31 (Primary Stage Group A); 2) Day 30 (Primary Stage Group B); 3) Day 80 (Secondary Stage Group A); 4) Day 30 (Secondary Stage Group B)
Secondary outcomes (11)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by concomitant medication check
Measured: 1) From screening visit to day 45 (Primary Stage Group A); 2) From screening visit to day 44 (Primary Stage Group B); 3) From screening visit to day 94 (Secondary Stage Group A); 4) From screening visit to day 44 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by Adverse Events
Measured: 1) From screening visit to day 45 (Primary Stage Group A); 2) From screening visit to day 44 (Primary Stage Group B); 3) From screening visit to day 94 (Secondary Stage Group A); 4) From screening visit to day 44 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by symptom directed physical exam
Measured: 1) From screening visit to day 45 (Primary Stage Group A); 2) From screening visit to day 44 (Primary Stage Group B); 3) From screening visit to day 94 (Secondary Stage Group A); 4) From screening visit to day 44 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by vital signs
Temperature, blood pressure, heart rate, and respiratory rate
Measured: 1) From screening visit to day 45 (Primary Stage Group A); 2) From screening visit to day 44 (Primary Stage Group B); 3) From screening visit to day 94 (Secondary Stage Group A); 4) From screening visit to day 44 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by ECG
12 lead ECG with calculation of corrected QT interval (Fredericia)
Measured: 1) From screening visit to day 21 (Primary Stage Group A); 2) From screening visit to day 28 (Primary Stage Group B); 3) From screening visit to day 70 (Secondary Stage Group A); 4) From screening visit to day 28 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by Urinalysis
Glucose, ketones, blood, pH, proteins, nitrites and leucocytes Pregnancy test for females of childbearing potential (urine) Drug screen
Measured: ) From screening visit to day 21 (Primary Stage Group A); 2) From screening visit to day 28 (Primary Stage Group B); 3) From screening visit to day 70 (Secondary Stage Group A); 4) From screening visit to day 28 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured haematology
- Coulter count with differential
- Clotting screen; PT, APTT, Fibrinogen
Measured: 1) From screening visit to day 45 (Primary Stage Group A); 2) From screening visit to day 44 (Primary Stage Group B); 3) From screening visit to day 94 (Secondary Stage Group A); 4) From screening visit to day 44 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by clinical chemistry
Serum Biochemistry - Including sodium, potassium, urea, creatinine, total cholesterol and triglycerides, calcium, phosphate, liver enzymes (ALT, AST, GGT), albumin, glucose.
Measured: 1) From screening visit to day 45 (Primary Stage Group A); 2) From screening visit to day 44 (Primary Stage Group B); 3) From screening visit to day 94 (Secondary Stage Group A); 4) From screening visit to day 44 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by Adherence questioning/ pill count
Measured: 1) Days 14 and 21 (Primary Stage Group A); 2) Days 7 and 28 (Primary Stage Group B); 3) Days 14, 21, 63, and 70 (Secondary Stage Group A); 4) Days 7 and 28 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz in HIV negative healthy volunteers, as measured by CNS symptoms questionnaire
Measured: 1) Days 2 and 21 (Primary Stage Group A); 2) Days 2, 21, 51, and 70 (Secondary Stage Group A)
Relationship between genetic polymorphisms and exposure to the studied drugs.
Preliminary comparison between genotype and phenotype
Measured: Sample taken at baseline (if consented)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
Why it stopped: Study is on hold whilst a grant application for further funding is put together
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Marta Boffito, Principal investigator, Chelsea & Westminster HospitalSteve Rannard, Study director, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631473
- Sponsor's protocol ID
- SSAT 055
- Status last verified
- Dec 2016
- First submitted
- 6 Jan 2015
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Efavirenz and Lopinavir Nano-formulations in HIV Negative Healthy Volunteers: an Adaptive Design Study
- ClinicalTrials.gov ID
- NCT02631473
- Acronym / sponsor ID
- SSAT 055
- Conditions
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study is on hold whilst a grant application for further funding is put together
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Collaborators
- University of Liverpool
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- First posted
- 16 Dec 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 is an open-label, prospective pharmacokinetic study investigating two antiretroviral agents in parallel and employing an adaptive design with two stages, whereby the results obtained in the primary stage inform the doses selected for investigation in the secondary stage
Detailed description
The objectives of this study are:
Primary
- To investigate the pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANO-efavirenz) in HIV negative healthy volunteers after single dose and a steady-state.
- To investigate the pharmacokinetics of a new pharmaceutical formulation of lopinavir (NANO-lopinavir) in HIV negative healthy volunteers
Secondary
- To investigate the safety and tolerability of NANO-efavirenz and NANO-lopinavir in HIV negative healthy volunteers
- To assess the bioequivalence of a selected single-dose of NANO-efavirenz to a single dose 600mg of efavirenz as Sustiva®
- To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1st Stage-Group A | Active comparator | Drug: 50mg NANO-efavirenz1. Day 1: 50 mg NANO-efavirenz single dose 2. Days 4-21: 50 mg NANO-efavirenz OD (once daily) |
| 1st Stage-Group B | Active comparator | Drug: 400mg NANO-Lopinavir, Drug: 200mg NANO-Lopinavir, Drug: 100mg Ritonavir1. Days 1-7: 400mg NANO-lopinavir BID (twice daily) 2. Days 8-21: Wash-out period 3. Days: 22-28: 200mg NANO-lopinavir BID plus 100mg Ritonavir (Norvir) BID |
| 2nd Stage-Group A-Group 1-Dose level 1 | Active comparator | Drug: 300mg NANO-Efavirenz, Drug: 600mg Sustiva1. 21 Days: 300mg NANO-efavirenz OD 2. 4 weeks: Wash-out period 3. 21 days: 600mg Sustiva OD |
| 2nd Stage-Group A-Group 2-Dose level 2 | Active comparator | Drug: 200mg NANO-Efavirenz, Drug: 400mg Sustiva1. 21 Days: 200mg NANO-efavirenz OD 2. 4 weeks: Wash-out period 3. 21 days: 400mg Sustiva OD |
| 2nd Stage-Group B-Arm 1 | Active comparator | Drug: Kaletra® (lopinavir 400mg/ritonavir 100mg), Drug: +/- 200mg NANO-Lopinavir, Drug: +/- 200mg ritonavir NORVIR1. 7 days: Kaletra® (lopinavir400mg/ritonavir100mg) BD 2. 2 weeks: Wash-out period 3. 7 days: NANO-lopinavir (200mg +/- ritonavir®) |
| 2nd Stage-Group B-Arm 2 | Active comparator | Drug: Kaletra® (lopinavir 400mg/ritonavir 100mg), Drug: +/- 200mg NANO-Lopinavir, Drug: +/- 200mg ritonavir NORVIR1. 7 days: NANO-lopinavir (200mg +/- ritonavir Norvir) 2. 2 weeks: Wash-out period 3. 7 days: Kaletra® (lopinavir400mg/ritonavir100mg) BD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Volunteers must meet all of the following inclusion criteria within 28 days prior to the baseline visit:
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
- Male or non-pregnant, non-lactating females
- Between 18 to 65 years, inclusive
- Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive
Key exclusion criteria (16 listed)
- Volunteers who meet any of the following exclusion criteria are not to be enrolled in this study.
- Any significant acute or chronic medical illness including hypertension (BP persistently >140/90 mmHg) or hypotension (BP persistently <90/60 mmHg)
- Prolongation of ECG intervals: PR > 200 msec or QTcF > 450 msec.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations.
- Liver transaminase (ALT or AST > 1.25 x the upper limit of the normal range)
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 |
|---|---|---|
| 50mg NANO-efavirenzOD | Drug | 1st Stage-Group A |
| 400mg NANO-LopinavirBID | Drug | 1st Stage-Group B |
| 200mg NANO-LopinavirAlso: EfavirenzBID | Drug | 1st Stage-Group B |
| 100mg RitonavirAlso: NorvirBID | Drug | 1st Stage-Group B |
| 300mg NANO-EfavirenzOD | Drug | 2nd Stage-Group A-Group 1-Dose level 1 |
| 600mg SustivaAlso: EfavirenzOD | Drug | 2nd Stage-Group A-Group 1-Dose level 1 |
| 200mg NANO-EfavirenzOD | Drug | 2nd Stage-Group A-Group 2-Dose level 2 |
| Kaletra® (lopinavir 400mg/ritonavir 100mg)Also: Lopinavir/RitonavirBID | Drug | 2nd Stage-Group B-Arm 1, 2nd Stage-Group B-Arm 2 |
| +/- 200mg NANO-LopinavirBID | Drug | 2nd Stage-Group B-Arm 1, 2nd Stage-Group B-Arm 2 |
| +/- 200mg ritonavir NORVIRAlso: RitonavirBID | Drug | 2nd Stage-Group B-Arm 1, 2nd Stage-Group B-Arm 2 |
| 400mg SustivaAlso: Efavirenz | Drug | 2nd Stage-Group A-Group 2-Dose level 2 |
Primary outcome
The pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANOefavirenz) and lopinavir (NANOlopinavir) in HIV negative healthy volunteers, as measured by Ctrough
Time frame: Assessed from baseline visit (day 1) to : 1) Day 31 (Primary Stage Group A); 2) Day 30 (Primary Stage Group B); 3) Day 80 (Secondary Stage Group A); 4) Day 30 (Secondary Stage Group B)
Trough concentration (Ctrough) is defined as the concentration at 24 hours after the observed drug dose.
The pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANOefavirenz) and lopinavir (NANOlopinavir) in HIV negative healthy volunteers, as measured by Cmax
Time frame: Assessed from baseline visit (day 1) to : 1) Day 31 (Primary Stage Group A); 2) Day 30 (Primary Stage Group B); 3) Day 80 (Secondary Stage Group A); 4) Day 30 (Secondary Stage Group B)
Cmax is defined as the maximum observed plasma concentration
The pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANOefavirenz) and lopinavir (NANOlopinavir) in HIV negative healthy volunteers, as measured by t1/2
Time frame: Assessed from baseline visit (day 1) to : 1) Day 31 (Primary Stage Group A); 2) Day 30 (Primary Stage Group B); 3) Day 80 (Secondary Stage Group A); 4) Day 30 (Secondary Stage Group B)
t1/2 is defined as the elimination half-life
The pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANOefavirenz) and lopinavir (NANOlopinavir) in HIV negative healthy volunteers, as measured by Tmax
Time frame: Assessed from baseline visit (day 1) to : 1) Day 31 (Primary Stage Group A); 2) Day 30 (Primary Stage Group B); 3) Day 80 (Secondary Stage Group A); 4) Day 30 (Secondary Stage Group B)
Tmax is defined as the time point at Cmax (Tmax)
The pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANOefavirenz) and lopinavir (NANOlopinavir) in HIV negative healthy volunteers, as measured by total drug exposure
Time frame: Assessed from baseline visit (day 1) to : 1) Day 31 (Primary Stage Group A); 2) Day 30 (Primary Stage Group B); 3) Day 80 (Secondary Stage Group A); 4) Day 30 (Secondary Stage Group B)
Total drug exposure will be expressed as the area under the plasma concentration-time curve (AUC): from 0-12 (AUC0-12h) and 0-56 hours (AUC0-56h) for lopinavir; or 0-24 (AUC0-24h) and 0-228 hours (AUC0-24h) for efavirenz.
11 secondary outcomes
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by concomitant medication check
Time frame: 1) From screening visit to day 45 (Primary Stage Group A); 2) From screening visit to day 44 (Primary Stage Group B); 3) From screening visit to day 94 (Secondary Stage Group A); 4) From screening visit to day 44 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by Adverse Events
Time frame: 1) From screening visit to day 45 (Primary Stage Group A); 2) From screening visit to day 44 (Primary Stage Group B); 3) From screening visit to day 94 (Secondary Stage Group A); 4) From screening visit to day 44 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by symptom directed physical exam
Time frame: 1) From screening visit to day 45 (Primary Stage Group A); 2) From screening visit to day 44 (Primary Stage Group B); 3) From screening visit to day 94 (Secondary Stage Group A); 4) From screening visit to day 44 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by vital signs
Time frame: 1) From screening visit to day 45 (Primary Stage Group A); 2) From screening visit to day 44 (Primary Stage Group B); 3) From screening visit to day 94 (Secondary Stage Group A); 4) From screening visit to day 44 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by ECG
Time frame: 1) From screening visit to day 21 (Primary Stage Group A); 2) From screening visit to day 28 (Primary Stage Group B); 3) From screening visit to day 70 (Secondary Stage Group A); 4) From screening visit to day 28 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by Urinalysis
Time frame: ) From screening visit to day 21 (Primary Stage Group A); 2) From screening visit to day 28 (Primary Stage Group B); 3) From screening visit to day 70 (Secondary Stage Group A); 4) From screening visit to day 28 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured haematology
Time frame: 1) From screening visit to day 45 (Primary Stage Group A); 2) From screening visit to day 44 (Primary Stage Group B); 3) From screening visit to day 94 (Secondary Stage Group A); 4) From screening visit to day 44 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by clinical chemistry
Time frame: 1) From screening visit to day 45 (Primary Stage Group A); 2) From screening visit to day 44 (Primary Stage Group B); 3) From screening visit to day 94 (Secondary Stage Group A); 4) From screening visit to day 44 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz and NANOlopinavir in HIV negative healthy volunteers, as measured by Adherence questioning/ pill count
Time frame: 1) Days 14 and 21 (Primary Stage Group A); 2) Days 7 and 28 (Primary Stage Group B); 3) Days 14, 21, 63, and 70 (Secondary Stage Group A); 4) Days 7 and 28 (Secondary Stage Group B)
Safety and tolerability of NANOefavirenz in HIV negative healthy volunteers, as measured by CNS symptoms questionnaire
Time frame: 1) Days 2 and 21 (Primary Stage Group A); 2) Days 2, 21, 51, and 70 (Secondary Stage Group A)
Relationship between genetic polymorphisms and exposure to the studied drugs.
Time frame: Sample taken at baseline (if consented)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
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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.
Marta Boffito principal investigator
Chelsea & Westminster Hospital
Steve Rannard study director
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 50mg NANO-efavirenz, 400mg NANO-Lopinavir and 200mg NANO-Lopinavir in people with HIV, run by St Stephens Aids Trust at 1 site in United Kingdom.
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 19 inclusion and 16 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: paused, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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?
Results are not available in the source record.
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?
The pharmacokinetics of a new pharmaceutical formulation of efavirenz (NANOefavirenz) and lopinavir (NANOlopinavir) in HIV negative healthy volunteers, as measured by Ctrough (time frame: Assessed from baseline visit (day 1) to : 1) Day 31 (Primary Stage Group A); 2) Day 30 (Primary Stage Group B); 3) Day 80 (Secondary Stage Group A); 4) Day 30 (Secondary Stage Group B)). 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 Dec 2016.