HIVPhase 1NCT01469520
Bioequivalence Study of Pediatric Formulations to Treat HIV Infection
A Phase 1 study testing Epivir®, Retrovir® and Viramune®, Lamivudine, Zidovudine and nevirapine and Lamivudine, zidovudine, nevirapine in people with HIV and AIDS, run by Elim Pediatric Pharmaceuticals Inc. at 1 site in Nigeria.
Trial summary
The purpose of the study is to determine the bioavailability/bioequivalence of two pediatric formulations (tablet and reconstitutable suspension) of lamivudine/zidovudine/ nevirapine in comparison to an innovator product. Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Epivir®, Retrovir® and Viramune®, Lamivudine, Zidovudine and nevirapine and Lamivudine, zidovudine, nevirapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNigeria
- Study dates
- Oct 2010to Dec 2011
- 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 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The eligibility criteria included adults between 22 and 55 years;
- Healthy as determined on the basis of a pre-trial physical examination, medical history, electrocardiogram and the results of blood biochemistry and hematology tests;
- Subject was competent and willing to sign informed consent form voluntarily after being given all the detailed information about the study;
- Willing to be hospitalized for the 24-hour intensive sampling period.
Who cannot join
- The exclusion criteria was hypersensitivity to study drugs;
- Abnormal laboratory biochemistry values;
- Smokers;
- Any clinically significant diseases or findings during the screening, medical history or physical examination that, in the opinion of the investigator, may interfere with the study;
- Treatment with experimental drugs within 30 days prior to study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Three-way Crossover Bioequivalence Study of Pediatric Formulations of Lamivudine/Zidovudine/Nevirapine Using Healthy Adult Volunteers
The purpose of the study is to determine the bioavailability/bioequivalence of two pediatric formulations (tablet and reconstitutable suspension) of lamivudine/zidovudine/ nevirapine in comparison to an innovator product. Establishing the bioequivalence of a newly developed age-appropriate fixed dose combination of lamivudine/zidovudine/ nevirapine as an oral dispersible tablet or a reconstitutable suspension for children is invaluable for future product registration and availability of the products to children, thus filling the void in pediatric HIV/AIDS therapy.
Read the detailed description
Volunteer Selection and Size: The International Conference on Harmonization (ICH) guideline E11 on clinical investigation of medicinal products in the pediatric population suggests that for relative bioavailability comparison of pediatric formulations, adult subjects may be used. Therefore, the study will be performed in a minimum of 24 healthy adult subjects. However, 29 healthy adults will be enrolled to allow for two possible drop-outs and for three subjects that may develop hypersensitivity to nevirapine which is known for its hypersensitivity side effect, in form of rashes.
In anticipation of such reactions,10% more of the 26 subjects will be added to the group. This will make a total of 29 volunteers during the study. Advertisements announcing the study will be posted at the Bowen University Teaching Hospital two months before the commencement of the study to invite volunteers.
Informed Consent Procedure: The volunteers will be screened using a questionnaire (see attached). The language of communication will be English or a local language used by the community. Researchers will explain to the volunteers on an individual basis, the nature of the study, what would be expected of them and their rights. Volunteers may choose to drop out of the study at any time without any restrictions. Volunteers will be informed that the screening procedure also includes physical examination and laboratory test. Following informed consent, using Consent to Participate Form (see attached) and counseling, volunteers may be enrolled for the study.
A baseline laboratory tests for: packed cell volume, white blood cell count with differentiation, platelet estimation, liver function (aspartate aminotransferase [SGOT], alanine aminotransferase [SGPT]), renal function (serum creatinine), blood urea nitrogen (BUN), pregnancy test (females only), HIV/AIDS, and hepatitis B and C tests will be done two weeks prior to dosing. Volunteers may not consume alcohol, tobacco, caffeine containing products, herbal or other drugs during the study.
Eligibility: The inclusion criteria are as follows: Adult males and females found normal on the basis of a pre-trial physical examination, medical history and the results of blood biochemistry and hematology tests; subject is competent and willing to sign informed consent form voluntarily after being given all the detailed information about the study; willingness to be hospitalized for a 24-hour intensive sampling period.
Exclusion criteria:
- Hypersensitivity to study drugs, alcoholism, anemia, evidence of pregnancy
- Abnormal laboratory test; smokers;
- Any clinically significant diseases or findings during the screening medical history or physical examination that, in the opinion of the investigator, may interfere with the study;
- Treatment with experimental or prescribed drugs within 30 days prior to the beginning of the study
Confidentiality: Volunteer's name as it appears on the questionnaire will be linked to an identification number. All other documents will have only the identification number instead of your name. The name will not be used in any public document. All written materials and consent forms will be stored in a locked file in the researcher's office. All materials will be destroyed by shredding five years after the completion of the research.
- Being tested
- Epivir®, Retrovir® and Viramune®, Lamivudine, Zidovudine and nevirapine, Lamivudine, zidovudine, nevirapine
- Keywords
- HIV, AIDS, Treatment
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epivir®, Retrovir® and Viramune®Drug
Also called Lamivudine, Zidovudine, Nevirapine
12 mL of Epivir® (lamivudine) 10 mg/mL solution plus 24 ml of Retrovir® (zidovudine) 10 mg/mL syrup plus and 20 mL of Viramune® (nevirapine) of 10 mg/mL
Lamivudine, Zidovudine and nevirapineDrug
Also called Lamivudine, Zidovudine, Nevirapine
20 mL of reconstituted granules for suspension containing lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per 5 mL of suspension
Lamivudine, zidovudine, nevirapineDrug
Also called Lamivudine, Zidovudine, Nevirapine
Lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per tablet.
| Study group | Role | What they receive |
|---|---|---|
| Reference | Active comparator | Co-administered liquid mixture of Epivir® (lamivudine) solution, Retrovir® (zidovudine)and Viramune® (nevirapine) Receives: Drug: Epivir®, Retrovir® and Viramune® |
| Test product | Active comparator | Fixed dose combination of lamivudine, zidovudine and nevirapine reconstitutable suspension Receives: Drug: Lamivudine, Zidovudine and nevirapine; Drug: Lamivudine, zidovudine, nevirapine |
| Test Product | Active comparator | Fixed dose combination combination (Lamivudine, Zidovudine and Nevirapine)tablet Receives: Drug: Lamivudine, Zidovudine and nevirapine; Drug: Lamivudine, zidovudine, nevirapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence between the tests and reference drugs
The BE criterion established by the Food and Drug administration requires that the 90 % confidence interval of the ratio of suspension or tablet/co-administered liquid mixtures of the individual drugs for all the three parameters (Cmax, AUC0-t, AUC0-∞)should lie within 80 to 125 % range.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startOct 2010
- Primary completionNov 2011 (estimated)
- Study completionDec 2011 (estimated)
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 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elim Pediatric Pharmaceuticals Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moji C Adeyeye, Ph.D, Principal investigator, Elim Pediatric Pharmaceuticals Inc. and Roosevelt UniversityDaniel A Gbadero, MD, Study director, Bowen University Teaching Hospital, Ogbomoso, Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469520
- Sponsor's protocol ID
- RU 2010-73
- Other IDs
- 2010-73
- Status last verified
- Nov 2011
- First submitted
- 4 Nov 2011
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ellis JC, L'homme RF, Ewings FM, Mulenga V, Bell F, Chileshe R, Molyneux E, Abernethy J, van Oosterhout JJ, Chintu C, Walker AS, Gibb DM, Burger DM. Nevirapine concentrations in HIV-infected children treated with divided fixed-dose combination antiretroviral tablets in Malawi and Zambia. Antivir Ther. 2007;12(2):253-60.
PubMed 17503667
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Three-way Crossover Bioequivalence Study of Pediatric Formulations of Lamivudine/Zidovudine/Nevirapine Using Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01469520
- Acronym / sponsor ID
- RU 2010-73
- Keywords
- HIV, AIDS, Treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Elim Pediatric Pharmaceuticals Inc.University, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 10 Nov 2011 (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.
The purpose of the study is to determine the bioavailability/bioequivalence of two pediatric formulations (tablet and reconstitutable suspension) of lamivudine/zidovudine/ nevirapine in comparison to an innovator product. Establishing the bioequivalence of a newly developed age-appropriate fixed dose combination of lamivudine/zidovudine/ nevirapine as an oral dispersible tablet or a reconstitutable suspension for children is invaluable for future product registration and availability of the products to children, thus filling the void in pediatric HIV/AIDS therapy.
Detailed description
Volunteer Selection and Size: The International Conference on Harmonization (ICH) guideline E11 on clinical investigation of medicinal products in the pediatric population suggests that for relative bioavailability comparison of pediatric formulations, adult subjects may be used. Therefore, the study will be performed in a minimum of 24 healthy adult subjects. However, 29 healthy adults will be enrolled to allow for two possible drop-outs and for three subjects that may develop hypersensitivity to nevirapine which is known for its hypersensitivity side effect, in form of rashes.
In anticipation of such reactions,10% more of the 26 subjects will be added to the group. This will make a total of 29 volunteers during the study. Advertisements announcing the study will be posted at the Bowen University Teaching Hospital two months before the commencement of the study to invite volunteers.
Informed Consent Procedure: The volunteers will be screened using a questionnaire (see attached). The language of communication will be English or a local language used by the community. Researchers will explain to the volunteers on an individual basis, the nature of the study, what would be expected of them and their rights. Volunteers may choose to drop out of the study at any time without any restrictions. Volunteers will be informed that the screening procedure also includes physical examination and laboratory test. Following informed consent, using Consent to Participate Form (see attached) and counseling, volunteers may be enrolled for the study.
A baseline laboratory tests for: packed cell volume, white blood cell count with differentiation, platelet estimation, liver function (aspartate aminotransferase [SGOT], alanine aminotransferase [SGPT]), renal function (serum creatinine), blood urea nitrogen (BUN), pregnancy test (females only), HIV/AIDS, and hepatitis B and C tests will be done two weeks prior to dosing. Volunteers may not consume alcohol, tobacco, caffeine containing products, herbal or other drugs during the study.
Eligibility: The inclusion criteria are as follows: Adult males and females found normal on the basis of a pre-trial physical examination, medical history and the results of blood biochemistry and hematology tests; subject is competent and willing to sign informed consent form voluntarily after being given all the detailed information about the study; willingness to be hospitalized for a 24-hour intensive sampling period.
Exclusion criteria:
- Hypersensitivity to study drugs, alcoholism, anemia, evidence of pregnancy
- Abnormal laboratory test; smokers;
- Any clinically significant diseases or findings during the screening medical history or physical examination that, in the opinion of the investigator, may interfere with the study;
- Treatment with experimental or prescribed drugs within 30 days prior to the beginning of the study
Confidentiality: Volunteer's name as it appears on the questionnaire will be linked to an identification number. All other documents will have only the identification number instead of your name. The name will not be used in any public document. All written materials and consent forms will be stored in a locked file in the researcher's office. All materials will be destroyed by shredding five years after the completion of the research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference | Active comparator | Drug: Epivir®, Retrovir® and Viramune®Co-administered liquid mixture of Epivir® (lamivudine) solution, Retrovir® (zidovudine)and Viramune® (nevirapine) |
| Test product | Active comparator | Drug: Lamivudine, Zidovudine and nevirapine, Drug: Lamivudine, zidovudine, nevirapineFixed dose combination of lamivudine, zidovudine and nevirapine reconstitutable suspension |
| Test Product | Active comparator | Drug: Lamivudine, Zidovudine and nevirapine, Drug: Lamivudine, zidovudine, nevirapineFixed dose combination combination (Lamivudine, Zidovudine and Nevirapine)tablet |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The eligibility criteria included adults between 22 and 55 years;
- Healthy as determined on the basis of a pre-trial physical examination, medical history, electrocardiogram and the results of blood biochemistry and hematology tests;
- Subject was competent and willing to sign informed consent form voluntarily after being given all the detailed information about the study;
- Willing to be hospitalized for the 24-hour intensive sampling period.
Key exclusion criteria (5 listed)
- The exclusion criteria was hypersensitivity to study drugs;
- Abnormal laboratory biochemistry values;
- Smokers;
- Any clinically significant diseases or findings during the screening, medical history or physical examination that, in the opinion of the investigator, may interfere with the study;
- Treatment with experimental drugs within 30 days prior to study entry.
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 |
|---|---|---|
| Epivir®, Retrovir® and Viramune®Also: Lamivudine, Zidovudine, Nevirapine12 mL of Epivir® (lamivudine) 10 mg/mL solution plus 24 ml of Retrovir® (zidovudine) 10 mg/mL syrup plus and 20 mL of Viramune® (nevirapine) of 10 mg/mL | Drug | Reference |
| Lamivudine, Zidovudine and nevirapineAlso: Lamivudine, Zidovudine, Nevirapine20 mL of reconstituted granules for suspension containing lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per 5 mL of suspension | Drug | Test Product, Test product |
| Lamivudine, zidovudine, nevirapineAlso: Lamivudine, Zidovudine, NevirapineLamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per tablet. | Drug | Test Product, Test product |
Primary outcome
Bioequivalence between the tests and reference drugs
Time frame: 90 days
The BE criterion established by the Food and Drug administration requires that the 90 % confidence interval of the ratio of suspension or tablet/co-administered liquid mixtures of the individual drugs for all the three parameters (Cmax, AUC0-t, AUC0-∞)should lie within 80 to 125 % range.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
- Background: PubMed 17503667Ellis JC, L'homme RF, Ewings FM, Mulenga V, Bell F, Chileshe R, Molyneux E, Abernethy J, van Oosterhout JJ, Chintu C, Walker AS, Gibb DM, Burger DM. Nevirapine concentrations in HIV-infected children treated with divided fixed-dose combination antiretroviral tablets in Malawi and Zambia. Antivir Ther. 2007;12(2):253-60.
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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.
Moji C Adeyeye, Ph.D principal investigator
Elim Pediatric Pharmaceuticals Inc. and Roosevelt University
Daniel A Gbadero, MD study director
Bowen University Teaching Hospital, Ogbomoso, Nigeria
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 Epivir®, Retrovir® and Viramune®, Lamivudine, Zidovudine and nevirapine and Lamivudine, zidovudine, nevirapine in people with HIV and AIDS, run by Elim Pediatric Pharmaceuticals Inc. at 1 site in Nigeria.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Nov 2011. 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 Nigeria. 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?
Bioequivalence between the tests and reference drugs (time frame: 90 days). 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 NCT01469520, 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 10 Nov 2011.