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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00086359 |
Pregnant women infected with HIV who take anti-HIV medications during pregnancy lower the risk of passing HIV to their infants. This study will compare how well two different combinations of anti-HIV medications control HIV in pregnancy, and whether these combinations of drugs are effective in preventing HIV from being transmitted from a pregnant woman to her baby. The two combinations are abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) and zidovudine/lamivudine (ZDV/3TC) plus lopinavir/ritonavir (LPV/RTV).
Condition | Intervention | Phase |
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HIV Infections |
Drug: Abacavir sulfate, lamivudine, and zidovudine Drug: Lamivudine/zidovudine Drug: Lopinavir/ritonavir |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | A Phase III Randomized Trial of the Safety and Antiretroviral Effects of Zidovudine/Lamivudine/Abacavir Versus Zidovudine/Lamivudine/Lopinavir/Ritonavir in the Prevention of Perinatal Transmission of HIV |
Estimated Enrollment: | 880 |
Study Start Date: | July 2004 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
One pill of abacavir/lamivudine/zidovudine twice daily
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Drug: Abacavir sulfate, lamivudine, and zidovudine
one pill twice daily
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B: Experimental
One pill of zidovudine/lamivudine and four pills of lopinavir/ritonavir twice daily.
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Drug: Lamivudine/zidovudine
one pill twice daily
Drug: Lopinavir/ritonavir
four pills twice daily
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Antiretroviral therapy (ART) in pregnancy has dramatically reduced the rates of perinatal HIV transmission. Many pregnant women infected with HIV may not meet the criteria for treatment as set forth by the Department of Health and Human Services' guidelines and would not be started on therapy if they were not pregnant. Pregnant women are prescribed a variety of treatment regimens; the optimum regimen for pregnant women who plan to discontinue therapy after delivery is unknown. An optimum regimen would account for the need for maximum viral suppression, minimal fetal toxicity, and preservation of future therapeutic options for the mother. This study will compare an all nucleoside reverse transcriptase inhibitor (NRTI) regimen of ABC/3TC/ZDV with a standard protease inhibitor (PI) regimen of LPV/RTV and 3TC/ZDV. This study was initially designed for women who plan to take antiretrovirals only while pregnant and do not meet the criteria for treatment initiation if not pregnant. However, pregnant women who have taken ART for 180 days or less or have taken ZDV monotherapy for a total of 8 weeks or less prior to entering this study are eligible for Version 2.0 of this study.
Women in this study will be randomly assigned to one of two groups. Women in Group A will receive one pill ABC/3TC/ZDV twice a day. Women in Group B will receive one pill 3TC/ZDV and 4 pills LPV/RTV twice a day. Women will take their assigned medications until they go into labor. Once in labor, women will be given zidovudine through intravenous (IV) infusion; they will stop taking oral zidovudine but will continue with their other medications. After delivery, all infants will be given zidovudine for six weeks.
Women will have study visits every 2 weeks for the first 8 weeks of treatment, and then every 4 weeks until Week 28. Depending on where a woman is in her pregnancy when she enrolls in the study, she will also have study visits at Weeks 20, 28, and 34 of her pregnancy. At each visit, women will have a medical interview, a physical exam, and an obstetrical exam; blood and urine collection will occur at these visits. Mothers will undergo a fetal ultrasound at Week 20. Adherence, health status, and behavior assessments will occur at selected visits prior to delivery.
After delivery, women will stop taking the study medications but will continue to have study visits at approximately 6, 12, 24, 36, 48, and 52 weeks after delivery. Medical history and a physical exam will occur at all visits for mothers postpartum. Blood collection will occur at every postpartum visit; urine collection will occur 12, 24, and 48 weeks postpartum; health status and behavior assessments will occur at most visits postpartum. Infants will have study visits at 2, 16, and 24 weeks after birth. A medical history, physical exam, and laboratory tests will be conducted at the infant study visits. Women will also be asked to enroll their infants in PACTG 219C, a long-term study that follows infants who are born to HIV infected mothers.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Note: The pharmacokinetics testing portion of this study has been discontinued in Version 2.0 of this protocol.
Inclusion Criteria for Mothers:
Exclusion Criteria for Mothers:
Study Chair: | Andrew D. Hull, MD | Department of Reproductive Medicine, Division of Perinatal Medicine, University of California, San Diego School of Medicine |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | PACTG P1039 |
Study First Received: | June 30, 2004 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00086359 |
Health Authority: | United States: Food and Drug Administration |
Treatment Naive Perinatal Transmission Mother-to-Child Transmission MTCT Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Lopinavir Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Lamivudine Zidovudine Abacavir Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |