Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy
HIV Infections

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Naive
Eligibility Criteria
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
Sites / Locations
- Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
- Byramjee Jeejeebhoy Government Medical College CRS
- Chennai Antiviral Research and Treatment (CART) CRS
- Blantyre CRS
- Wits Helen Joseph Hospital CRS (Wits HJH CRS)
- Durban International CRS
- Kilimanjaro Christian Medical CRS
- Joint Clinical Research Center (JCRC)/Kampala CRS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
7-day 3TC/ZDV
21-day 3TC/ZDV
7-day FTC/TDF
21-day FTC/TDF
7-day LPV/r
21-day LPV/r
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r