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Sponsored by: |
Radboud University |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00294892 |
Primary
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 |
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HIV Infections |
Drug: carbamazepine and nevirapine Drug: Nevirapine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics 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) |
Estimated Enrollment: | 144 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Carbamazepine: Active Comparator
An oral dose of 400mg Carbamazepine is added to the 200mg oral dose Nevirapine intake prior delivery
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Drug: carbamazepine and nevirapine
Carbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor.
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Nevirapine: Placebo Comparator
Standard therapy of 200mg Nevirapine oral prior to delivery
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Drug: Nevirapine
Nevirapine 200mg is taken prior to delivery during labor.
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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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eva P. Muro, PhamD | +255 748468553 | muroeva123@yahoo.com |
Contact: Rafaella F. l'homme, Drs. | +31 24 3616405 | r.lhomme@akf.umcn.nl |
Tanzania | |
Kilimanjaro Christian Medical College | Recruiting |
Moshi, Tanzania | |
Sub-Investigator: W. Schimana, MD | |
Sub-Investigator: O. Oneko, MD |
Principal Investigator: | David M. Burger, Dr. | Radboud University (RUNMC) |
Study ID Numbers: | VITA1 |
Study First Received: | February 21, 2006 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00294892 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
HIV mother to child transmission; MTCT nevirapine resistance pharmacokinetics Treatment Naive |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral Carbamazepine HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Sensory System Agents Therapeutic Uses Analgesics Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Tranquilizing Agents Anti-HIV Agents Immune System Diseases Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents Antiviral Agents Pharmacologic Actions Analgesics, Non-Narcotic Lentivirus Infections Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |