HIV InfectionsPhase 2NCT00273975
Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients
A Phase 2 study testing Nevirapine, Lamivudine and Zidovudine in people with HIV Infections, run by Boehringer Ingelheim at 4 sites in South Africa.
Trial summary
Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve paediatric patients. Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine, Lamivudine and Zidovudine
- How many people
- 123 participants
- Where
- 4 sitesSouth Africa
- Study dates
- Jan 2002to Dec 2004
- 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 3 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients between 3 months and 16 years of age at day 28 of the study.
- Evidence of HIV-1 infection
- Patients who are antiretroviral drug naive
- Plasma viral load detectable
- CD4 >=50 cells/cc3
- Written informed permission
- Active assent given by the patient if the child is capable of understanding the given information
- Reasonable probability for completion of the trial
Who cannot join
- Any significant disease, other than HIV
- Any acute illness within 2 weeks prior to Day 0
- Patients requiring the continued use of inhibitors or inducers of P450 metabolic enzymes
- Patients requiring systematic treatment with CYP3A4 substrates
- Patients with malabsorption, severe chronic diarrhea
- Receipt of any cytotoxic therapy for malignancy
Show all 9Show fewer
- Current grade 3 or 4 clinical or laboratory toxicity
- Pregnancy or breast-feeding
- Females of childbearing potential not using adequate contraception. allergy or known drug hypersensitivity to any of the study drugs intravenous drug abuse, alcohol or substance abuse
Trial locations and contacts
4 sites in 1 country.
South Africa4 sites
Groote Schuur Hospital
Cape Town, 7900
Boehringer Ingelheim Investigational Site
Pretoria
Boehringer Ingelheim Investigational Site
Soweto, 2013
Boehringer Ingelheim Investigational Site
Tygerberg, 7505
About this study
Official title: A Randomised Open Label Multi-centre Trial to Evaluate the Pharmacokinetic, Efficacy and Safety Parameters of Nevirapine 150mg/m2 and Nevirapine 4 or 7 mg/kg When Administered in Combination With AZT and 3TC for 48 Weeks in Antiretroviral naïve Paediatric Patients.
Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve paediatric patients.
Read the detailed description
A randomised open label multi-centre trial to evaluate the pharmacokinetic, efficacy and safety parameters of nevirapine 150mg/m2 and nevirapine 4 or 7mg/kg when administered in combination with ZDV and 3TC for 48 weeks in antiretroviral naive pediatric patients.
Primary objective: To evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 in antiretroviral drug naive pediatric patients.
Secondary objective: To assess efficacy and safety of nevirapine 150 mg/m2 and nevirapine 4/7mg/kg after 24 and 48 weeks of treatment
Study Hypothesis:
Evaluation of recent pharmacokinetic data has suggested that a dose based on body surface area rather than body weight might be a better therapeutic regimen to achieve steady state plasma concentrations. The goal in this study was to determine if a Nevirapine suspension dose of 150 mg/m2 BID, following a two week lead-in of 150 mg/m2 QD, produces plasma nevirapine steady state concentrations of 4 - 6 ?g/mL in all age groups as was observed in adult safety and efficacy trials.
Comparison(s):
ACTG 245
- Conditions
- HIV Infections
- Being tested
- Nevirapine, Lamivudine, Zidovudine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
LamivudineDrug
ZidovudineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve over one dosing interval (AUCτ)
Measured: 1, 3 and 6 hours on Day 28
Maximum observed concentration (Cmax)
Measured: 1, 3 and 6 hours on Day 28
Minimum observed concentration (Cmin)
Measured: 1, 3 and 6 hours on Day 28
Oral clearance (Dose/AUC) at steady state
Measured: 1, 3 and 6 hours on Day 28
Secondary outcomes (11)
Change in HIV-1 RNA count
Measured: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48
Virologic Response
Measured: 48 weeks
Time to Virologic Suppression
Measured: 48 weeks
Virologic Failure
Measured: 48 weeks
Time to Virologic Failure
Measured: 48 weeks
Treatment Failure
Measured: 48 weeks
Time to Treatment Failure
Measured: 48 weeks
Change in CD4+ cell count
Measured: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48
Change in CD4+ percent
Measured: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48
Occurrence of Adverse Events
Measured: 48 weeks
Occurrence of Rash
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startJan 2002
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 123 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. South Africa (Pty.) Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273975
- Sponsor's protocol ID
- 1100.1368
- Status last verified
- Oct 2013
- First submitted
- 9 Jan 2006
- Last updated
- 31 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Open Label Multi-centre Trial to Evaluate the Pharmacokinetic, Efficacy and Safety Parameters of Nevirapine 150mg/m2 and Nevirapine 4 or 7 mg/kg When Administered in Combination With AZT and 3TC for 48 Weeks in Antiretroviral naïve Paediatric Patients.
- ClinicalTrials.gov ID
- NCT00273975
- Acronym / sponsor ID
- 1100.1368
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004
- First posted
- 10 Jan 2006 (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.
Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve paediatric patients.
Detailed description
A randomised open label multi-centre trial to evaluate the pharmacokinetic, efficacy and safety parameters of nevirapine 150mg/m2 and nevirapine 4 or 7mg/kg when administered in combination with ZDV and 3TC for 48 weeks in antiretroviral naive pediatric patients.
Primary objective: To evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 in antiretroviral drug naive pediatric patients.
Secondary objective: To assess efficacy and safety of nevirapine 150 mg/m2 and nevirapine 4/7mg/kg after 24 and 48 weeks of treatment
Study Hypothesis:
Evaluation of recent pharmacokinetic data has suggested that a dose based on body surface area rather than body weight might be a better therapeutic regimen to achieve steady state plasma concentrations. The goal in this study was to determine if a Nevirapine suspension dose of 150 mg/m2 BID, following a two week lead-in of 150 mg/m2 QD, produces plasma nevirapine steady state concentrations of 4 - 6 ?g/mL in all age groups as was observed in adult safety and efficacy trials.
Comparison(s):
ACTG 245
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male or female patients between 3 months and 16 years of age at day 28 of the study.
- Evidence of HIV-1 infection
- Patients who are antiretroviral drug naive
- Plasma viral load detectable
- CD4 >=50 cells/cc3
Key exclusion criteria (9 listed)
- Any significant disease, other than HIV
- Any acute illness within 2 weeks prior to Day 0
- Patients requiring the continued use of inhibitors or inducers of P450 metabolic enzymes
- Patients requiring systematic treatment with CYP3A4 substrates
- Patients with malabsorption, severe chronic diarrhea
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 |
|---|---|---|
| Nevirapine | Drug | – |
| Lamivudine | Drug | – |
| Zidovudine | Drug | – |
Primary outcome
Area under the concentration-time curve over one dosing interval (AUCτ)
Time frame: 1, 3 and 6 hours on Day 28
Maximum observed concentration (Cmax)
Time frame: 1, 3 and 6 hours on Day 28
Minimum observed concentration (Cmin)
Time frame: 1, 3 and 6 hours on Day 28
Oral clearance (Dose/AUC) at steady state
Time frame: 1, 3 and 6 hours on Day 28
11 secondary outcomes
Change in HIV-1 RNA count
Time frame: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48
Virologic Response
Time frame: 48 weeks
Time to Virologic Suppression
Time frame: 48 weeks
Virologic Failure
Time frame: 48 weeks
Time to Virologic Failure
Time frame: 48 weeks
Treatment Failure
Time frame: 48 weeks
Time to Treatment Failure
Time frame: 48 weeks
Change in CD4+ cell count
Time frame: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48
Change in CD4+ percent
Time frame: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48
Occurrence of Adverse Events
Time frame: 48 weeks
Occurrence of Rash
Time frame: 48 weeks
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 31 Oct 2013.
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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.
Boehringer Ingelheim Study Coordinator study chair
B.I. South Africa (Pty.) Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nevirapine, Lamivudine and Zidovudine in people with HIV Infections, run by Boehringer Ingelheim at 4 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 8 inclusion and 9 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 31 Oct 2013. 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 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. 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?
Area under the concentration-time curve over one dosing interval (AUCτ) (time frame: 1, 3 and 6 hours on Day 28). The study lists 4 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 31 Oct 2013; AzTrials last refreshed its copy on 6 Nov 2026.