Status:
COMPLETED
Nevirapine Clearance After Short-term Highly Active Antiretroviral Therapy (HAART) for Prevention of Mother to Child Transmission of HIV (PMTCT)
Lead Sponsor:
Thai Red Cross AIDS Research Centre
Collaborating Sponsors:
Chulalongkorn University
Queen Savang Vadhana Memorial Hospital, Thailand
Conditions:
NVP Plasma Level
NVP Related Mutation
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Three-drug combination of antiretroviral regimens has been used increasingly in HIV-infected pregnant women worldwide, both for the prevention of mother to child transmission of HIV (PMTCT) and for wo...
Eligibility Criteria
Inclusion
- Willing and able to provide 2 separated written informed consents to take part in the Thai Red Cross PMTCT program and in the study
- Female and aged between 18-45 years
- Documented HIV-1 infection
- Pregnant for a maximum of 36 weeks at the first dose of study medication
- Baseline CD4 cell count \>250 cells/mm3
- Intend to discontinue ART after delivery
Exclusion
- History of significant reaction or allergy to the drugs that may be used in the study
- Antiretroviral (ARV)-experienced including previous ARV use for the prevention of mother-to-child transmission of HIV
- Documented NVP- or 3TC-resistant HIV-1 strains
- Concomitant use of medications that interfere with NVP plasma level
- Serum aspartate transaminase (AST) or alanine transaminase (ALT) \>1.25 times the upper limit of normal
- Inability to understand the nature and extent of the trial procedures required
- Pregnant woman, in the opinion of the investigator, should not participate in the study
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00872872
Start Date
May 1 2008
End Date
April 1 2021
Last Update
July 12 2021
Active Locations (1)
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1
Thai Red Cross AIDS Research Centre
Bangkok, Thailand, 10330