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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Female

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, potentially ruling out some treatment options in the future. The purpose of this study is to determine which of three anti-HIV drug regimens most effectively reduces the development of maternal NVP resistance in HIV infected pregnant women. The effectiveness of short-term (7 day therapy) versus long-term (21-day therapy) regimens will also be compared.

The study hypotheses are: 1) intrapartum SD NVP with a 21-day course of antiretroviral therapy (ART) results in less frequent selection of NVP-resistant HIV-1 variants than intrapartum SD NVP with a 7-day course of ART, and 2) a 7- or 21-day course of lamivudine/zidovudine (3TC/ZDV), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), or lopinavir/ritonavir (LPV/r) following SD NVP will not select nucleoside reverse transcriptase inhibitor (NRTI)- or protease inhibitor (PI)- resistant HIV-1 variants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Lamivudine, zidovudine drug combination; Lopinavir; Nevirapine; Ritonavir; Tenofovir; Zidovudine

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