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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00099632 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Emtricitabine/tenofovir disoproxil fumarate Drug: Lamivudine/zidovudine Drug: Lopinavir/ritonavir Drug: Nevirapine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Maintaining Options for Mothers Study (MOMS): A Phase II Randomized Comparison of Three Antiretroviral Strategies Administered for 7 or 21 Days to Reduce the Emergence of Nevirapine Resistant HIV-1 Following a Single Intrapartum Dose of Nevirapine |
Estimated Enrollment: | 420 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Prior to labor, participants will be randomly assigned to receive NVP at the onset of labor. All participants in Group 1 will receive 3TC/ZDV after delivery for the duration of the trial unless otherwise specified by the investigator |
Drug: Lamivudine/zidovudine
150 mg lamivudine/300 mg zidovudine tablets taken orally daily
Drug: Nevirapine
200 mg tablet taken orally daily for the first 14 days before taking 200 mg tablet orally twice daily
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2: Experimental
Prior to labor, participants will be randomly assigned to receive NVP at the onset of labor. All participants in Group 2 will receive FTC/TDF after delivery for the duration of the trial unless otherwise specified by the investigator |
Drug: Emtricitabine/tenofovir disoproxil fumarate
200 mg emtricitabine/300 mg tenofovir disoproxil fumarate tablet taken orally daily
Drug: Nevirapine
200 mg tablet taken orally daily for the first 14 days before taking 200 mg tablet orally twice daily
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3: Experimental
Prior to labor, participants will be randomly assigned to receive NVP at the onset of labor. All participants in Group 3 will receive LPV/r after delivery for the duration of the trial unless otherwise specified by the investigator |
Drug: Lopinavir/ritonavir
200 mg lopinavir/50 mg ritonavir tablet taken orally daily
Drug: Nevirapine
200 mg tablet taken orally daily for the first 14 days before taking 200 mg tablet orally twice daily
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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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Mothers:
Exclusion Criteria for Mothers:
Haiti | |
Institut National de Laboratoire et de Recherches Les Centres GHESKIO | Recruiting |
Port-au-Prince, Haiti | |
Contact: Patrice Severe, MD 509 222 2241 patsevere@gheskio.org | |
India | |
YRG Center for AIDS Research and Education | Recruiting |
Chennai, India, 60001-7 | |
Contact: Aylur Kailasom Srikrishnan, MBA 91 442 254 2929 krish@yrgcare.org | |
India, Maharashtra | |
BJ Medical College CRS | Not yet recruiting |
Pune, Maharashtra, India, 411001 | |
Contact: Nishi Suryavanshi, PhD 91-020-26052419 nishi@jhumitpune.com | |
Principal Investigator: Gowri Sastry, MD, MPH | |
Malawi | |
Univ. of Malawi | Recruiting |
Blantyre, Malawi | |
Contact: Sima TM Berendes, MPH (265) 018-60132 sberendes@jhu.medcol.mw | |
South Africa | |
University of Witwatersrand, CTU | Recruiting |
Johannesburg, South Africa | |
Contact: Pauline S. Vunandlala, BSc 27 11 717 2810 idsyndicate@witshealth.co.za | |
Principal Investigator: Ian M. Sanne, MD, FCP | |
University of KwaZulu-Natal, Nelson Mandela School of Medicine | Recruiting |
Durban, South Africa, 4013 SF | |
Contact: Fawzia Williamson 27 31 260 4365 amodf1@nu.ac.za | |
Principal Investigator: Umesh Gangaram Lalloo, MD |
Study Chair: | Gyrlande Bois, MD | Institute National de Laboratoire et de Recherches, Les Centres GHESKIO |
Study Chair: | Jane Hitti, MD, MPH | Department of Obstetrics/Gynecology, Perinatal Medicine, University of Washington Medical Center |
Study Chair: | Deborah McMahon, MD | Division of Infectious Diseases, Department of Medicine, University of Pittsburgh |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG A5207, MOMS |
Study First Received: | December 17, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00099632 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Treatment Naive |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors |
Virus Diseases Nevirapine Anti-Retroviral Agents Lopinavir Emtricitabine HIV Infections Ritonavir Sexually Transmitted Diseases Tenofovir Retroviridae Infections Tenofovir disoproxil |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Lopinavir Emtricitabine Therapeutic Uses Tenofovir Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Nevirapine HIV Infections |