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Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV

This study has been completed.
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00270296
First received: December 22, 2005
Last updated: April 27, 2017
Last verified: April 2017
  Purpose
Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child transmission (MTCT) of HIV in developed countries. However, little is known of the effectiveness of such regimens in developing countries, such as Botswana. This study will determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV) is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected pregnant women in Botswana.

Condition Intervention Phase
HIV Infections Drug: Trizivir Drug: Lamivudine/Zidovudine Drug: Lopinavir/Ritonavir Drug: Nevirapine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Lopinavir/Ritonavir/Combivir vs. Abacavir/Zidovudine/Lamivudine for Virologic Efficacy and the Prevention of Mother-to-Child HIV Transmission Among Breastfeeding Women With CD4 Counts Greater Than or Equal to 200 Cells/mm3 in Botswana

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Number of Participants With Virologic Suppression [ Time Frame: Throughout study, including breastfeeding, assessed up to 24 months ]
    Suppression of the plasma HIV-1 RNA level to less than 400 copies per milliliter

  • Number of HIV+ Infants [ Time Frame: Throughout study, including breastfeeding, assessed up to 24 months ]
    Number of infants with HIV-positive status


Enrollment: 730
Study Start Date: June 2006
Study Completion Date: September 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trizivir (TZV) Arm
Participants in the TZV Arm (Arm 1A) will be pregnant women who have CD4 counts of 200 cells/mm3 or more. As the intervention, they will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Drug: Trizivir
300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
Other Name: TZV
Experimental: Kaletra Arm
Participants in the Kaletra Arm (Arm 1B) will be pregnant women who have CD4 counts of 200 cells/mm3 or more. As the intervention, they will receive Lamivudine/Zidovudine (3TC/ZDV) and Lopinavir/Ritonavir (LPV/RTV) twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Drug: Lamivudine/Zidovudine
150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
Other Names:
  • 3TC/ZDV
  • Combivir
Drug: Lopinavir/Ritonavir
400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily
Other Name: LPV/RTV
Experimental: Nevirapine (NVP) Arm
Participants in the NVP Arm (Arm 2) will be pregnant women who have have CD4 counts less than 200 cells/mm3. These participants will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.
Drug: Nevirapine
200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily
Other Name: NVP

Detailed Description:

While perinatal HIV infection has become rare in developed countries through the use of highly active antiretroviral therapy (HAART), it remains a serious problem in developing countries. Botswana has a population of approximately 1.7 million; the prevalence of HIV in Botswana is about 37.4%. In the developed world, HAART has revolutionized the prevention of MTCT among nonbreastfed infants. This trial will compare the effectiveness of a protease inhibitor (PI)-based regimen versus a triple nucleoside reverse transcriptase inhibitor (NRTI)-based regimen in preventing MTCT of HIV.

This study will last up to 24 months for mothers and their children. Participants will be stratified based on their CD4 count at screening. Women with CD4 counts of 200 cells/mm3 or more will be in one of two treatment groups and will be randomly assigned to receive either TZV twice daily or LPV/RTV and 3TC/ZDV twice daily. Once in labor, treatment group participants will continue to take their assigned HAART regimen and will also be given additional ZDV. Women with CD4 counts less than 200 cells/mm3 will receive nevirapine (NVP) once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.

Shortly after birth, infants will receive single-dose NVP. A 1-month supply of ZDV will be provided to the mother to administer daily to her child. Mothers will stop HAART at 6 months postpartum or when they stop breastfeeding, whichever occurs earlier. A clinical evaluation, blood collection, and HIV prevention counseling will occur at all maternal visits. An obstetrical exam and physical exam will occur at selected visits. Women will provide at least four samples of breast milk during the first 5 months postpartum. For infants, a clinical evaluation will occur at every visit, and a physical exam and blood collection will occur at selected visits.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Mothers:

  • HIV-infected
  • At least at 26th week of pregnancy (treatment group) or 18th week of pregnancy (observational group) but not beyond the 34th week of pregnancy
  • Able to complete study visits until at least 6 months postpartum
  • Citizen of Botswana

Exclusion Criteria for Mothers:

  • Taken ARVs for more than 1 week, other than ZDV, during current or prior pregnancy. Women who have received single-dose NVP in a prior pregnancy are not excluded.
  • Certain abnormal laboratory values
  • Plan to formula feed
  • Known fetal abnormalities that suggest the fetus will not survive to 6 months of gestational age
  • Known allergy or medical contraindication to any of the study drugs
  • Require certain medications
  • Previous participation in the "Prevention of Milk-Borne Transmission of HIV-1C in Botswana" (Mashi) study
  • Currently incarcerated
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270296

Locations
Botswana
Princess Marina Hosp., BHP Study Clinic, Gaborone Shapiro CRS
Gaborone, Botswana
Athlone Hosp., BHP Study Clinic, Lobatse Shapiro CRS
Lobatse, Botswana
Deborah Reteif Hosp., BHP Study Clinic, Mochudi Shapiro CRS
Mochudi, Botswana
Scottish Livingstone Hosp., BHP Study Clinic, Molepolole Shapiro CRS
Molepolole, Botswana
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Harvard School of Public Health
Investigators
Principal Investigator: Roger Shapiro, MD, MPH Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Botswana-Harvard School of Public Health Partnership for Research and Education
Principal Investigator: Claire Moffat, MD, MPH Department of Immunology and Infectious Diseases, Harvard School of Public Health, Botswana-Harvard School of Public Health Partnership for Research and Education
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00270296     History of Changes
Other Study ID Numbers: BHP 016
U01AI064002 ( U.S. NIH Grant/Contract )
Study First Received: December 22, 2005
Results First Received: March 14, 2017
Last Updated: April 27, 2017

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Naive
MTCT
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
Lamivudine
Zidovudine
Nevirapine
Abacavir
Lamivudine, zidovudine drug combination
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Antimetabolites
Cytochrome P-450 CYP3A Inducers

ClinicalTrials.gov processed this record on September 21, 2017