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Ensayos clínicos

Ensayos clínicos

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

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00099632, ACTG A5207
  • Concluido

Propósito del estudio

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.

Afección:Fase:
Infecciones por el VIH
Fase 2

Detalles del estudio

The World Health Organization (WHO) currently recommends giving HIV infected pregnant women SD NVP prior to birth to prevent MTCT of HIV. However, 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 mother; as a result, future treatment options may be limited for these HIV infected women. The purpose of the study is to determine which of three ART regimens most effectively deters the development of maternal NVP resistance in HIV infected pregnant women postpartum. This study will also compare the effectiveness of short-term versus long-term ART in discouraging the development of maternal NVP resistance.



Some mothers in this study may receive ZDV monotherapy prior to SD NVP administration; initiation of ZDV monotherapy will be at the discretion of the site investigator and will not be provided by this study. Prior to labor, mothers will be randomly assigned to receive SD NVP at the onset of labor and one of three postpartum ART regimens: Group A will receive 3TC/ZDV; Group B will receive FTC/TDF; and Group C will receive LPV/r. In addition, participants will be randomly assigned to receive 7 or 21 days of their assigned postpartum treatment.



Mothers will be followed for 96 weeks following delivery; there will be 11 study visits for mothers during the study. At the onset of labor, medical and medication history, a targeted physical exam, and an obstetrical exam will occur. Additional physical exams will occur on Day 1 and Weeks 1 and 3. Blood collection will occur at 8 study visits between Weeks 3 and 96. Infants will be followed for up to 96 weeks after birth; there will be 8 study visits for infants during the study. Infants who have ever been breastfed will have study visits at Weeks 16, 24, 48, and 96, and at about 1 and 2 years of age. A physical exam, medication history, and blood collection will occur at each infant visit. Mothers and infants may be prescribed continuing ART, but such ART will not be provided by this study. Breastfeeding mothers are encouraged to enroll their infants in ACTG A5190, an observational study of the effects of maternal ART on infants born to HIV infected women.The World Health Organization (WHO) currently recommends giving HIV infected pregnant women SD NVP prior to birth to prevent MTCT of HIV. However, 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 mother; as a result, future treatment options may be limited for these HIV infected women. The purpose of the study is to determine which of three ART regimens most effectively deters the development of maternal NVP resistance in HIV infected pregnant women postpartum. This study will also compare the effectiveness of short-term versus long-term ART in discouraging the development of maternal NVP resistance.



Some mothers in this study may receive ZDV monotherapy prior to SD NVP administration; initiation of ZDV monotherapy will be at the discretion of the site investigator and will not be provided by this study. Prior to labor, mothers will be randomly assigned to receive SD NVP at the onset of labor and one of three postpartum ART regimens: Group A will receive 3TC/ZDV; Group B will receive FTC/TDF; and Group C will receive LPV/r. In addition, participants will be randomly assigned to receive 7 or 21 days of their assigned postpartum treatment.



Mothers will be followed for 96 weeks following delivery; there will be 11 study visits for mothers during the study. At the onset of labor, medical and medication history, a targeted physical exam, and an obstetrical exam will occur. Additional physical exams will occur on Day 1 and Weeks 1 and 3. Blood collection will occur at 8 study visits between Weeks 3 and 96. Infants will be followed for up to 96 weeks after birth; there will be 8 study visits for infants during the study. Infants who have ever been breastfed will have study visits at Weeks 16, 24, 48, and 96, and at about 1 and 2 years of age. A physical exam, medication history, and blood collection will occur at each infant visit. Mothers and infants may be prescribed continuing ART, but such ART will not be provided by this study. Breastfeeding mothers are encouraged to enroll their infants in ACTG A5190, an observational study of the effects of maternal ART on infants born to HIV infected women.

Criterios de inclusión

    for Mothers:
    • HIV infected
    • CD4 count 250 cells/mm3 or greater within 30 days of study entry
    • Pregnant with a viable fetus at 28 to 38 weeks of pregnancy
    • Willing to give birth to baby in a hospital or clinic
    • Written informed consent from parent or guardian, if applicable

Criterios de exclusión

    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
    • Require certain medications

Centros de estudio/contactos

Haiti

    Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS, Port-au-Prince, 6110, Haiti

Maharashtra

    Byramjee Jeejeebhoy Government Medical College CRS, Pune, Maharashtra, 411001, India

Tamil Nadu

    Chennai Antiviral Research and Treatment (CART) CRS, Chennai, Tamil Nadu, 600113, India

    Blantyre CRS, Blantyre, Tamil Nadu, 600113, Malawi

Gauteng

    Wits Helen Joseph Hospital CRS (Wits HJH CRS), Johannesburg, Gauteng, 2092, South Africa

KwaZulu-Natal

    Durban International CRS, Westville, KwaZulu-Natal, 3610, South Africa

    Kilimanjaro Christian Medical CRS, Moshi, KwaZulu-Natal, 3610, Tanzania

    Joint Clinical Research Center (JCRC)/Kampala CRS, Kampala, KwaZulu-Natal, 3610, Uganda

Actualizado: 25 de junio del 2007

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