HIV InfectionsPhase 2NCT00294892
Pharmacokinetics Study on Nevirapine Resistance in Tanzania
A Phase 2 study testing carbamazepine and nevirapine and Nevirapine in people with HIV Infections, run by Radboud University Medical Center at 1 site in Tanzania.
Trial summary
Primary pharmacokinetics of single dose nevirapine the effect of single dose carbamazepine on the pk of single dose nevirapine resistance against nevirapine before and after. follow-up on HIV status newborns relation between nevirapine levels in cord blood and plasma Secondary safety of single dose nevirapine and… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- carbamazepine and nevirapine and Nevirapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteTanzania
- Study dates
- Feb 2006to Jun 2010
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- HIV infected
- antiretroviral naive
- not intending to relocate out of area during study
- willing to adhere to follow up scheme
- ability and willing to give written consent
- pregnant between 18 and 40 years
- willing and able to regularly attend the Antenatal clinic
Who cannot join
- serious illness that requires systemic treatment or hospitalization
- any condition that would compromise subject's ability to participate
- previously treated for HIV with antiretroviral agents, including single dose nevirapine used for MTCT
- inability to understand the nature and extent of the trial and procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Single Dose Carbamazepine on the Pharmacokinetics of Single Dose Nevirapine (Viramune, NVP) and Development of NVP Resistance, PMTCT Program of Moshi, Tanzania (VITA1)
Primary
- pharmacokinetics of single dose nevirapine
- the effect of single dose carbamazepine on the pk of single dose nevirapine
- resistance against nevirapine before and after.
- follow-up on HIV status newborns
- relation between nevirapine levels in cord blood and plasma
Secondary
- safety of single dose nevirapine and nevirapine/carbamazepine
Hypothesis:
Single dose carbamazepine decreases development of resistance to nevirapine in HIV positive pregnant Tanzanian women by decreasing nevirapine half-life.
Read the detailed description
Without the use of preventative measures, the risk of mother-to-child transmission (MTCT) of HIV-1 is estimated to vary between 25 and 48%. The regimen of single dose of nevirapine to the mother just before delivery and a single dose of nevirapine to the newborn within 24 - 72 hours after birth reduces the risk of MTCT by 50%, is affordable in many situations and is therefore standard of care in many African countries, like Tanzania. Recent studies, however, have shown that this single dose to the mother can induce the occurrence of nevirapine resistance in a large number of mothers. The mechanism of occurrence of nevirapine resistance already after a single dose is most likely related to the long elimination half-life of the drug. The subtherapeutic plasma levels present the perfect environment for the occurrence of resistance as the concentrations are subinhibitory for several days.
- Conditions
- HIV Infections
- Being tested
- carbamazepine and nevirapine, Nevirapine
- Keywords
- HIV, mother to child transmission; MTCT, nevirapine resistance, pharmacokinetics, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbamazepine and nevirapineDrug
Carbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor.
NevirapineDrug
Nevirapine 200mg is taken prior to delivery during labor.
| Study group | Role | What they receive |
|---|---|---|
| Carbamazepine | Active comparator | An oral dose of 400mg Carbamazepine is added to the 200mg oral dose Nevirapine intake prior delivery Receives: Drug: carbamazepine and nevirapine |
| Nevirapine | Placebo comparator | Standard therapy of 200mg Nevirapine oral prior to delivery Receives: Drug: Nevirapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cord blood will be taken less than 30 minutes after delivery
Measured: 0 - 30 min after delivery
Blood samples from mother will be taken less than 30 minutes after delivery to measure viral load and CD4 count.
Measured: 0 - 30 min after delivery
Blood samples will be drawn from mother and child at week 1 (day 6-8), week 2 (day 13-15) and week 3 (day 20-22)
Measured: day 6 - 22 after delivery
From all samples plasma nevirapine and if applicable carbamazepine levels will be determined in women and newborns.
Measured: 0 30 min after delivery - week 3 after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionSep 2009
- Study completionJun 2010
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 HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M. Burger, Dr., Principal investigator, Radboud University (RUNMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294892
- Sponsor's protocol ID
- VITA1
- Status last verified
- Nov 2020
- First submitted
- 21 Feb 2006
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Muro EP, Fillekes Q, Kisanga ER, L'homme R, Aitken SC, Mariki G, Van der Ven AJ, Dolmans W, Schuurman R, Walker AS, Gibb DM, Burger DM. Intrapartum single-dose carbamazepine reduces nevirapine levels faster and may decrease resistance after a single dose of nevirapine for perinatal HIV prevention. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):266-73. doi: 10.1097/QAI.0b013e31824234d8.
PubMed 22134145
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Single Dose Carbamazepine on the Pharmacokinetics of Single Dose Nevirapine (Viramune, NVP) and Development of NVP Resistance, PMTCT Program of Moshi, Tanzania (VITA1)
- ClinicalTrials.gov ID
- NCT00294892
- Acronym / sponsor ID
- VITA1
- Conditions
- HIV Infections
- Keywords
- HIV, mother to child transmission; MTCT, nevirapine resistance, pharmacokinetics, Treatment Naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Feb 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.
Primary
- pharmacokinetics of single dose nevirapine
- the effect of single dose carbamazepine on the pk of single dose nevirapine
- resistance against nevirapine before and after.
- follow-up on HIV status newborns
- relation between nevirapine levels in cord blood and plasma
Secondary
- safety of single dose nevirapine and nevirapine/carbamazepine
Hypothesis:
Single dose carbamazepine decreases development of resistance to nevirapine in HIV positive pregnant Tanzanian women by decreasing nevirapine half-life.
Detailed description
Without the use of preventative measures, the risk of mother-to-child transmission (MTCT) of HIV-1 is estimated to vary between 25 and 48%. The regimen of single dose of nevirapine to the mother just before delivery and a single dose of nevirapine to the newborn within 24 - 72 hours after birth reduces the risk of MTCT by 50%, is affordable in many situations and is therefore standard of care in many African countries, like Tanzania. Recent studies, however, have shown that this single dose to the mother can induce the occurrence of nevirapine resistance in a large number of mothers. The mechanism of occurrence of nevirapine resistance already after a single dose is most likely related to the long elimination half-life of the drug. The subtherapeutic plasma levels present the perfect environment for the occurrence of resistance as the concentrations are subinhibitory for several days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbamazepine | Active comparator | Drug: carbamazepine and nevirapineAn oral dose of 400mg Carbamazepine is added to the 200mg oral dose Nevirapine intake prior delivery |
| Nevirapine | Placebo comparator | Drug: NevirapineStandard therapy of 200mg Nevirapine oral prior to delivery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- HIV infected
- antiretroviral naive
- not intending to relocate out of area during study
- willing to adhere to follow up scheme
- ability and willing to give written consent
Key exclusion criteria (4 listed)
- serious illness that requires systemic treatment or hospitalization
- any condition that would compromise subject's ability to participate
- previously treated for HIV with antiretroviral agents, including single dose nevirapine used for MTCT
- inability to understand the nature and extent of the trial and procedures
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 |
|---|---|---|
| carbamazepine and nevirapineCarbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor. | Drug | Carbamazepine |
| NevirapineNevirapine 200mg is taken prior to delivery during labor. | Drug | Nevirapine |
Primary outcome
Cord blood will be taken less than 30 minutes after delivery
Time frame: 0 - 30 min after delivery
Blood samples from mother will be taken less than 30 minutes after delivery to measure viral load and CD4 count.
Time frame: 0 - 30 min after delivery
Blood samples will be drawn from mother and child at week 1 (day 6-8), week 2 (day 13-15) and week 3 (day 20-22)
Time frame: day 6 - 22 after delivery
From all samples plasma nevirapine and if applicable carbamazepine levels will be determined in women and newborns.
Time frame: 0 30 min after delivery - week 3 after delivery
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 Nov 2020.
- Derived from this study: PubMed 22134145Muro EP, Fillekes Q, Kisanga ER, L'homme R, Aitken SC, Mariki G, Van der Ven AJ, Dolmans W, Schuurman R, Walker AS, Gibb DM, Burger DM. Intrapartum single-dose carbamazepine reduces nevirapine levels faster and may decrease resistance after a single dose of nevirapine for perinatal HIV prevention. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):266-73. doi: 10.1097/QAI.0b013e31824234d8.
- J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):266-73. Intrapartum single-dose carbamazepine reduces nevirapine levels faster and may decrease resistance after a single dose of nevirapine for perinatal HIV prevention.Link provided by the sponsor.
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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.
David M. Burger, Dr. principal investigator
Radboud University (RUNMC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carbamazepine and nevirapine and Nevirapine in people with HIV Infections, run by Radboud University Medical Center at 1 site in Tanzania.
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 7 inclusion and 4 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 Nov 2020. 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 Tanzania. 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?
Cord blood will be taken less than 30 minutes after delivery (time frame: 0 - 30 min after delivery). 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?
On the ClinicalTrials.gov record for NCT00294892, 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 Nov 2020.