Status:
COMPLETED
One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine
Lead Sponsor:
Institut de Recherche pour le Developpement
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether providing zidovudine (ZDV) and didanosine (ddI) during labor and for one month postpartum can reduce the selection of nevirapine (NVP) resistance muta...
Detailed Description
A single nevirapine dose to the mother, with or without a dose to the child, in addition to oral ZDV prophylaxis starting from 28 weeks gestation has been proven to be highly effective in reducing fur...
Eligibility Criteria
Inclusion
- Meet all pre-entry criteria;
- Consent to participate and to be followed for the duration of the study;
- Present the following laboratory values within 14 days prior to inclusion:
- Hemoglobin \> 8.0 mg/dl
- Absolute neutrophil count \> 1000 cells/mm3
- Platelets \> 100,000 cells/mm3
- Serum creatinine \< 1.5 mg/dl (women with a serum creatinine \> 1.5 mg/dl must have a measured eight-hour urine creatinine clearance \> 70 ml/min)
- SGPT less than 10 times the upper limit of normal
- Amylase less than 150/L IU (this upper limit may change slightly depending on the normal range at the hospital laboratory).
Exclusion
- Evidence of pre-existing fetal anomalies incompatible with life;
- Known hypersensitivity to any benzodiazepine or to NVP;
- Receipt of antiretroviral agent other than ZDV;
- Receipt of non-allowed concomitant treatment or contraindication to ddI
- Concurrent participation in another clinical trial;
- Women with a CD4 count \<200/µL or history of oral candidiasis if they are not receiving pneumocystis carinii pneumonia (PCP) prophylaxis
- Any other contra-indicated drugs during ZDV+ddI treatment for the mother as well as the child (Contra-indicated drugs such as gancyclovir, isoniazid, linezolid, ethambutol, rifabutin, cidofovir are not allowed during the ZDV ddI treatment after delivery in order to prevent pharmacological interactions or overlapping toxicities.)
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT00142337
Start Date
December 1 2004
End Date
February 1 2009
Last Update
January 6 2012
Active Locations (32)
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1
Bhumibol Adulyadej Hospital
Bangkok, Bangkok, Thailand, 10220
2
Health Promotion Hospital Regional Center I
Bangkok, Bangkok, Thailand, 10220
3
Chacheongsao Hospital
Muang, Chacheongsao, Thailand, 24000
4
Prapokklao Hospital
Muang, Changwat Chanthaburi, Thailand, 22000