Status:
COMPLETED
Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
FEMALE
13+ years
Phase:
PHASE2
Brief Summary
HIV infected pregnant women may take single-dose nevirapine (SD NVP) prior to giving birth to prevent mother-to-child transmission (MTCT) of HIV. However, SD NVP may cause NVP resistance in the mother...
Detailed Description
A major disadvantage of giving SD NVP is the potential for maternal development of NVP resistance and additional resistance to other nonnucleoside reverse transcriptase inhibitors (NNRTI) in the mothe...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Mothers:
- HIV-1 infected
- CD4 count 250 cells/mm3 or greater within 30 days of study entry
- The following laboratory values obtained within 30 days prior to study entry: absolute neutropil count \>= 750/mm3; hemoglobin \>= 8.0 g/dL; platelet count \>= 50,000/mm3; calculated creatinine clearance (Cockcroft-Gault formula) \> 60 mL/min; AST(SGOT) and ALT(SGPT) \< 5 x ULN; total bilirubin \< 1.5 X ULN.
- Pregnant with a viable fetus at 28 to 38 weeks gestation at study entry.
- Willing to give birth to baby in a hospital or clinic
- Written informed consent from parent or guardian, if applicable
- Exclusion Criteria for Mothers:
- Any ART, including single-dose NVP, prior to study entry. Mothers who receive ZDV monotherapy prior to labor under the supervision of the site investigator are not excluded.
- Known allergy or sensitivity to study drugs or their formulations
- Current drug or alcohol abuse that may interfere with the study
- Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
- Hepatitis B surface antigen positive within 180 days prior to study entry
- Active tuberculosis infection requiring treatment
- Prior enrollment in this study
- Expect to use ART, except ZDV monotherapy, prior to onset of labor
- Expect to use ART other than study medications from delivery to 9 weeks postpartum
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
484 Patients enrolled
Trial Details
Trial ID
NCT00099632
Start Date
March 1 2006
End Date
November 1 2011
Last Update
November 4 2021
Active Locations (8)
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1
Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
Port-au-Prince, Haiti, 6110
2
Byramjee Jeejeebhoy Government Medical College CRS
Pune, Maharashtra, India, 411001
3
Chennai Antiviral Research and Treatment (CART) CRS
Chennai, Tamil Nadu, India, 600113
4
Blantyre CRS
Blantyre, Malawi