Nevirapine Clearance After Short-term Highly Active Antiretroviral Therapy (HAART) for Prevention of Mother to Child Transmission of HIV (PMTCT)
Information source: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: NVP Plasma Level; NVP Related Mutation; 3TC Related Mutation
Intervention: AZT/3TC 2 weeks after delivery (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Thai Red Cross AIDS Research Centre Overall contact: Nittaya Phanuphak, MD, Phone: 662 253 0996, Email: nittaya.p@chula.ac.th
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 women's own health. Use of these drugs in pregnant women solely for PMTCT
means that these drugs will need to be discontinued in the majority of women after delivery.
Certain antiretroviral regimens contain drugs with long half-life (drugs that stay in the
body for a longer period of time after discontinuation than other drugs in the same
regimen), such as nevirapine (NVP). HIV can easily develop resistance to NVP when NVP is the
only drug left in the body (similar to monotherapy). Given two other drugs for up to 1 week
after discontinue NVP (to mimic three-drug regimen while waiting for NVP elimination) can
help reduce, but not eliminate, the development of resistant virus.
Unfortunately, NVP-containing regimens are the most widely used regimens for pregnant women
in developing countries due to its low cost and its availability in fixed-dose combinations.
These study will explore how fast NVP is eliminated from women after delivery and to see if
given zidovudine/lamivudine (AZT/3TC) for 1 or 2 weeks after NVP discontinuation can help
reduce the development of NVP resistant virus.
Clinical Details
Official title: Nevirapine Plasma Level After Discontinuation of Short-term Antiretroviral Treatment for the Prevention of Mother-to-child Transmission of HIV and Development of Drug Resistant HIV-1 Variants With 1 or 2 Weeks Continuation of Zidovudine/Lamivudine in Women After Delivery
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Proportion of patients with detectable NVP plasma level at week 1, 2, 3 and 4 after NVP discontinuation
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Willing and able to provide 2 separated written informed consents to take part in the
Thai Red Cross PMTCT program and in the study
2. Female and aged between 18-45 years
3. Documented HIV-1 infection
4. Pregnant for a maximum of 36 weeks at the first dose of study medication
5. Baseline CD4 cell count >250 cells/mm3
6. Intend to discontinue ART after delivery
Exclusion Criteria:
1. History of significant reaction or allergy to the drugs that may be used in the study
2. Antiretroviral (ARV)-experienced including previous ARV use for the prevention of
mother-to-child transmission of HIV
3. Documented NVP- or 3TC-resistant HIV-1 strains
4. Concomitant use of medications that interfere with NVP plasma level
5. Serum aspartate transaminase (AST) or alanine transaminase (ALT) >1. 25 times the
upper limit of normal
6. Inability to understand the nature and extent of the trial procedures required
7. Pregnant woman, in the opinion of the investigator, should not participate in the
study
Locations and Contacts
Nittaya Phanuphak, MD, Phone: 662 253 0996, Email: nittaya.p@chula.ac.th
Thai Red Cross AIDS Research Centre, Patumwan, Bangkok 10330, Thailand; Recruiting Nittaya Phanuphak, MD, Phone: 662 253 0996, Email: nittaya.p@chula.ac.th
Additional Information
Starting date: May 2008
Last updated: May 11, 2015
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