Pharmacokinetics Study on Nevirapine Resistance in Tanzania
This study has been completed.
Sponsor:
Radboud University
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00294892
First received: February 21, 2006
Last updated: May 30, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: carbamazepine and nevirapine Drug: Nevirapine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Radboud University:
Primary Outcome Measures:
- Cord blood will be taken less than 30 minutes after delivery [ Time Frame: 0 - 30 min after delivery ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 144 |
| Study Start Date: | February 2006 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Carbamazepine
An oral dose of 400mg Carbamazepine is added to the 200mg oral dose Nevirapine intake prior delivery
|
Drug: carbamazepine and nevirapine
Carbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor.
|
|
Placebo Comparator: Nevirapine
Standard therapy of 200mg Nevirapine oral prior to delivery
|
Drug: Nevirapine
Nevirapine 200mg is taken prior to delivery during labor.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations More Information
Additional Information:
No publications provided by Radboud University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00294892 History of Changes |
| Other Study ID Numbers: | VITA1 |
| Study First Received: | February 21, 2006 |
| Last Updated: | May 30, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
HIV mother to child transmission; MTCT nevirapine resistance pharmacokinetics Treatment Naive |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Carbamazepine Nevirapine Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on March 14, 2013
