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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: | NCT00307151 |
A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a single dose to her infant has shown to be an effective way of reducing the rate of mother-to-child transmission (MTCT) of HIV. The purpose of this study is to compare the effectiveness of a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen versus a protease inhibitor (PI)-based regimen in HIV infected infants who have or have not been exposed to SD NVP.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Lamivudine Drug: Lopinavir/ritonavir Drug: Nevirapine Drug: Zidovudine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase II, Parallel, Randomized, Clinical Trial Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV Infected Infants Who Have and Have Not Previously Received Single Dose Nevirapine for Prevention of Mother-to-Child HIV Transmission |
Estimated Enrollment: | 452 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Previously received single dose nevirapine (SD NVP); randomly assigned to receive an NNRTI-based regimen. Now closed to enrollment. Lopinavir/ritonavir is now available to participants who achieved a virologic endpoint in this group.
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Drug: Lamivudine
4 mg/kg twice daily
Drug: Nevirapine
160 to 200 mg/m^2/dose to max 200 mg once daily for 14 days, then 160 to 200 mg/m^2/dose to max 200 mg twice daily
Drug: Zidovudine
180 mg/m^2 twice daily
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2: Active Comparator
Previously received SD NVP; randomly assigned to receive a PI-based regimen. Now closed to enrollment.
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Drug: Lamivudine
4 mg/kg twice daily
Drug: Nevirapine
160 to 200 mg/m^2/dose to max 200 mg once daily for 14 days, then 160 to 200 mg/m^2/dose to max 200 mg twice daily
Drug: Zidovudine
180 mg/m^2 twice daily
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3: Active Comparator
Have not previously received SD NVP; randomly assigned to receive an NNRTI-based regimen
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Drug: Lamivudine
4 mg/kg twice daily
Drug: Lopinavir/ritonavir
16/4 mg/kg twice daily for participants 2 months of age to less than 6 months of age; 12/3 mg/kg twice daily for participants at least 6 months of age and weighing less than 15 kg; 10/2.5 mg/kg twice daily for participants at least 6 months of age and weighing between 15 kg and 40kg; 400/100 mg twice daily for participants weighing more than 40 kg
Drug: Zidovudine
180 mg/m^2 twice daily
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4: Active Comparator
Have not previously received SD NVP; randomly assigned to receive a PI-based regimen
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Drug: Lamivudine
4 mg/kg twice daily
Drug: Lopinavir/ritonavir
16/4 mg/kg twice daily for participants 2 months of age to less than 6 months of age; 12/3 mg/kg twice daily for participants at least 6 months of age and weighing less than 15 kg; 10/2.5 mg/kg twice daily for participants at least 6 months of age and weighing between 15 kg and 40kg; 400/100 mg twice daily for participants weighing more than 40 kg
Drug: Zidovudine
180 mg/m^2 twice daily
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Single dose nevirapine (SD NVP) has greatly reduced the rate of mother-to-child transmission (MTCT) of HIV.
Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens are recommended for use by the World Health Organization (WHO) in resource-limited settings. However, research suggests that mothers and infants exposed to SD NVP experience higher virologic failure rates when treated with NNRTI-based regimens than their unexposed counterparts. Data show that the use of SD NVP is associated with NNRTI resistance in HIV infected women and infants. The purpose of this trial is to compare and evaluate the virologic responses to an NNRTI-based regimen versus a protease inhibitor (PI)-based regimen in HIV infected infants who have or have not been exposed to SD NVP intrapartum and after birth.
This study will last between 6 months and 4 years. Participants will be divided into two cohorts (Cohorts I and II); Cohort I participants previously received SD NVP, and Cohort II participants have not previously received SD NVP. Participants in both cohorts will be randomly assigned to receive either an NNRTI- or a PI-based regimen.
The NNRTI-based regimen will include NVP, zidovudine (ZDV) and lamivudine (3TC); the PI-based regimen will include lopinavir/ritonavir (LPV/r), ZDV and 3TC. If participants have adverse reactions to ZDV, stavudine (d4T) may be substituted, but may not be supplied by the study, depending on medication access within the site country.
There will be at least nine study visits. A physical exam, blood collection, and assessments of HIV-related symptoms will occur at all visits.
Based on a review of safety data in April 2009, enrollment in Cohort I was ended. Data from this and another, similar study (A5208) indicate that a PI-based regimen is clearly more effective for infants who received SD NVP.
Cohort II remains open for enrollment. Participants who were enrolled in Cohort I will continue to be followed.
Ages Eligible for Study: | 2 Months to 36 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for All Participants:
Inclusion Criteria for Cohort I: Closed to Enrollment
Confirmation of HIV infection may be made after 60 days of age.
Inclusion Criteria for Cohort II:
AND one or more of the following:
A. Study subject was born before single dose NVP was available for prevention of MTCT of HIV in the location of birth of study subject
B. Study subject was born before the biological mother's first positive HIV test
C. Site staff have another reason to believe the subject has not been exposed to NVP
Exclusion Criteria for All Participants:
Exclusion Criteria for Cohort I: Closed to Enrollment
Exclusion Criteria for Cohort II:
India, Maharashtra | |
BJ Medical College CRS | Recruiting |
Pune, Maharashtra, India, 411001 | |
Contact: Nishi Suryavanshi, PhD 91-020-26052419 nishi@jhumitpune.com | |
Principal Investigator: Gowri Sastry, MD, MPH | |
Malawi, Lilongwe | |
University of North Carolina Lilongwe CRS | Recruiting |
Mzimba Road, Lilongwe, Malawi | |
Contact: Kimberly Reynolds 265-1-755954 kreynolds@unclilongwe.org.mw | |
Principal Investigator: Francis Martinson, MPH, PhD, MB ChB | |
South Africa | |
University of Stellenbosch-Tygerberg Hospital, South Africa | Recruiting |
Cape Town, South Africa, 7700 | |
Contact: Joan Coetzee, CPN 278-327-59577 joan@sun.ac.za | |
Harriet Shezi Clinic at Chris Hani Baragwanath Hospital | Recruiting |
Soweto, South Africa, Bertsha | |
Contact: Angela Oosthuizen +27 (0) 11-933-9630 oosthuizenan@paedshiv.wits.ac.za | |
South Africa, Durban | |
Nelson R. Mandela School of Medicine, University of Kwazulu | Recruiting |
Natal, Durban, South Africa, 50202 | |
Contact: Enbavani Pillay 270-312-604729 Pillaye1@ukzn.ac.za | |
Principal Investigator: Raziya Bobat, MD | |
Tanzania, Moshi | |
Kilimanjaro Christian Medical CRS | Recruiting |
IDC Research Offices, Moshi, Tanzania | |
Contact: Julieta Giner 255-786-882498 giner001@mc.duke.edu | |
Principal Investigator: John A Crump, MB, ChB, DTM&H | |
Zambia | |
George Clinic CRS | Recruiting |
Lusaka, Zambia | |
Contact: Allison V. Verbe, MD allison@cidrz.org | |
Principal Investigator: Benjamin Chi, MD |
Study Chair: | Paul Palumbo, MD | Division of Infectious Diseases and International Health, Dartmouth-Hitchcock Medical Center |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | IMPAACT P1060, PACTG P1060 |
Study First Received: | March 24, 2006 |
Last Updated: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00307151 History of Changes |
Health Authority: | United States: Federal Government |
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 Lamivudine Antiviral Agents Immunologic Deficiency Syndromes |
Protease Inhibitors Reverse Transcriptase Inhibitors Virus Diseases Nevirapine 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 Lamivudine 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 HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |