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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

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
History of Changes
Purpose

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

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 Name:
  • 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

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

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

More Information

Additional Information:

Click here for more information about abacavir/lamivudine/zidovudine

Additional Information:

Click here for more information about lopinavir/ritonavir

Additional Information:

Click here for more information about lamivudine/zidovudine

Additional Information:

Click here for more information about nevirapine

Additional Information:

Click here for more information about HIV and pregnancy

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00270296   History of Changes  
Other Study ID Numbers: BHP 016  
  U01AI064002  
Study First Received: December 22, 2005  
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
Ritonavir
Lopinavir
Lamivudine
Zidovudine
Nevirapine
Abacavir
Lamivudine, zidovudine drug combination

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.