Pharmacokinetics Study on Nevirapine Resistance in Tanzania
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ClinicalTrials.gov Identifier: NCT00294892 |
Recruitment Status
:
Completed
First Posted
: February 22, 2006
Last Update Posted
: May 31, 2012
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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 or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: carbamazepine and nevirapine Drug: Nevirapine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 144 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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) |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Carbamazepine
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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Placebo Comparator: Nevirapine
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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- 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 ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294892
Tanzania | |
Kilimanjaro Christian Medical College | |
Moshi, Tanzania |
Principal Investigator: | David M. Burger, Dr. | Radboud University (RUNMC) |
Additional Information:
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 |
First Posted: | February 22, 2006 Key Record Dates |
Last Update Posted: | May 31, 2012 |
Last Verified: | May 2012 |
Keywords provided by Radboud University:
HIV mother to child transmission; MTCT nevirapine resistance pharmacokinetics Treatment Naive |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Nevirapine Carbamazepine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Anticonvulsants Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents |