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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: | NCT00109590 |
The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and lopinavir/ritonavir (LPV/r) will also be studied.
Study hypothesis: NVP resistance following single-dose NVP can be prevented with the concomitant administration of additional antiretroviral therapy (ART).
Condition | Intervention | Phase |
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HIV Infections |
Drug: Didanosine, enteric-coated Drug: Lopinavir/ritonavir Drug: Nevirapine Drug: Zidovudine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Phase II Study of the Pharmacokinetics of Nevirapine and the Incidence of Nevirapine Resistance Mutations in HIV-Infected Women Receiving a Single Intrapartum Dose of Nevirapine With the Concomitant Administration of Zidovudine/Didanosine or Zidovudine/Didanosine/Lopinavir/Ritonavir |
Estimated Enrollment: | 300 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Arm A participants will receive enteric-coated ddI and LPV/r beginning at the onset of labor and continuing through 7 days postpartum
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Drug: Didanosine, enteric-coated
given at the onset of labor
Drug: Lopinavir/ritonavir
twice daily
Drug: Nevirapine
single-dose at the onset of labor
Drug: Zidovudine
twice daily
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B: Experimental
Arm B participants will receive enteric-coated ddI beginning at the onset of labor and continuing through 30 days postpartum in addition to oral ZDV for 30 days postpartum.
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Drug: Didanosine, enteric-coated
given at the onset of labor
Drug: Nevirapine
single-dose at the onset of labor
Drug: Zidovudine
twice daily
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C: Experimental
Arm C participants will receive enteric-coated ddI and LPV/r beginning at the onset of labor and continuing through 30 days postpartum in addition to oral ZDV for 30 days postpartum.
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Drug: Didanosine, enteric-coated
given at the onset of labor
Drug: Lopinavir/ritonavir
twice daily
Drug: Nevirapine
single-dose at the onset of labor
Drug: Zidovudine
twice daily
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A single dose of nevirapine (NVP) given to an HIV infected pregnant woman in labor followed by a single dose to her infant has been shown to be a simple and effective means of reducing mother-to-child transmission (MTCT) of HIV among women who have not received ART during pregnancy. However, development of NVP- and other nonnucleoside reverse transcriptase inhibitor (NNRTI)-resistant virus is a concern. An optimal ART regimen that can prevent selection of resistant virus while efficiently preventing MTCT is needed. This study will evaluate 3 different ART strategies for preventing the development of NVP resistance in HIV infected pregnant women. NVP and LPV/r pharmacokinetics (PK) will also be evaluated in this study.
Participants will be randomly assigned to one of three study arms. All study participants will receive a single dose of oral NVP at the onset of labor, oral zidovudine (ZDV) at the onset of labor, and oral ZDV every three hours during labor. Arm A participants will receive enteric-coated didanosine (ddI) and LPV/r orally twice daily beginning at the onset of labor and continuing through 7 days postpartum; oral ZDV will also be taken twice daily for 7 days postpartum. Arm B participants will receive enteric-coated ddI beginning at the onset of labor and continuing through 30 days postpartum; oral ZDV will also be taken twice daily for 30 days postpartum. Arm C participants will receive enteric-coated ddI and LPV/r orally twice daily beginning at the onset of labor and continuing through 30 days postpartum; oral ZDV will also be taken twice daily for 30 days postpartum.
All women will be followed for at least 24 weeks postpartum. Women with resistance mutations identified within 8 weeks postpartum will be followed until 72 weeks postpartum. Infants will be followed until at least 12 weeks of age. There will be 11 study visits for women. Medical history assessment, a physical exam, and blood collection will occur at all visits. Blood collection for PK studies will occur at Days 10, 21, and 30. All women will be asked to complete an adherence questionnaire at Day 10; women assigned to Arms A and B will also be asked to complete an adherence questionnaire at Day 30. There will be 6 study visits for infants. Medical history assessment and a physical exam will occur at most visits; blood collection will occur at all visits.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Mothers:
Exclusion Criteria for Mothers:
Thailand | |
Chiang Mai University, Chiang Mai, Thailand | Recruiting |
Chiang Maii, Thailand | |
Contact: Daralak Tavornprasi +66-53-221966 daralak@rihes.cmu.ac.th | |
Siriraj Hospital | Recruiting |
Bangkok, Thailand | |
Contact: Nongluck Seetapun, BSc, MBA 665 381 4270/1x300 nseetapun@hotmail.com | |
Prachanukroh Hospital, Chiangrai | Recruiting |
Chiangrai, Thailand, 57000 | |
Contact: Noodchanee Maneerat (665) 371-1300 ext 274 | |
Institut de Recherche pour Developpement (IRD) | Recruiting |
Chiang Mai, Thailand, 50200 | |
Contact: Gonzague J. Jourdain, MD 66-53-814-2701 pactg@phpt.org | |
Chonburi Regional Hospital | Recruiting |
Chonburi, Thailand, 20000 | |
Contact: Donyapattra Ekkomonrat 661 945 7420 donyapattra@yahoo.com | |
Prapokklao Hospital | Recruiting |
Chantaburi, Thailand, 22000 | |
Contact: Kittima Karanmundee (663) 931-1099 | |
Bhumibol Adulyadej Hospital | Recruiting |
Bangkok, Thailand, 10120 | |
Contact: Jittra Suriyo (662) 212-1593 | |
Phayao Provincial Hospital Phayao | Recruiting |
Phayao, Thailand, 56000 | |
Contact: Somjai Yama (665) 442-7821 |
Study Chair: | Russell Van Dyke, MD | Tulane University Medical School |
Study Chair: | Gonzague J. Jourdain, MD | Program for HIV Prevention and Treatment / IRD054, Department of Immunology and Infectious Diseases, Harvard School of Public Health |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | PACTG P1032 |
Study First Received: | April 29, 2005 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00109590 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV Seronegativity Treatment Naive Pregnancy Perinatal Transmission |
Vertical Transmission Mother-To-Child Transmission MTCT |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors |
Reverse Transcriptase Inhibitors Virus Diseases Nevirapine Didanosine Anti-Retroviral Agents Lopinavir HIV Infections Ritonavir Sexually Transmitted Diseases Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Infection Reverse Transcriptase Inhibitors Lopinavir Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors 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 Didanosine HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |