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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
December 22, 2005
April 27, 2017
June 2006
March 2009   (Final data collection date for primary outcome measure)
  • 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
Virologic suppression to less than 400 copies/ml at delivery, regardless of whether or not randomized treatment is being taken at the time or to less than 400 copies/ml during the entire breastfeeding period
Complete list of historical versions of study NCT00270296 on ClinicalTrials.gov Archive Site
Not Provided
  • Virologic suppression to less that 400 copies/ml at both delivery and during the entire breastfeeding period, regardless of whether or not randomized treatment is being taken at the time of each measurement
  • virologic suppression to less than 50 copies/ml or 1,000 copies/ml at delivery, during the breastfeeding period, and both at delivery and during the breastfeeding period
  • HIV-1 RNA levels in plasma and in breast milk at delivery and at 1, 3, and 5 months postpartum
  • time from randomization to the first adverse event requiring discontinuation of any of the drugs that formed the initial regimen
  • time from randomization to the first Grade 3 or higher adverse event
  • occurrence of Grade 3 or higher adverse events by type, grade, body system, and association with study treatment
  • Premature birth and very premature birth, defined as 37 and 32 weeks gestation or less, respectively
  • Low birth weight and very low birth weight, defined as less than 2,500 g and less than 1,500 g, respectively
  • Growth and developmental delay, defined as standard norms and neurodevelopmental screening
  • Maternal mortality
  • Maternal morbidity, defined as occurrence of Grade 3 or 4 adverse events, hospitalizations, and AIDS-defining or AIDS-associated diagnoses
  • change in maternal CD4 count from baseline over time to 12 months postpartum
  • Infant mortality
  • Adherence, as measured by questionnaire and pill count
  • Occurrence of HIV-1 RNA genetic mutations associated with viral resistance in maternal plasma and breast milk and infant plasma among transmitting mother-infant pairs at the nearest time to transmission
  • LPV/RTV concentrations in the serum of 10 pregnant women, after 1 month of LPV/RTV and 3TC/ZDV
  • antiretroviral concentrations in breast milk and serum and in their infants' serum for all transmitting mother-infant pairs and a matched group of non-transmitting pairs
Not Provided
Not Provided
 
Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV
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
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider
Primary Purpose: Prevention
HIV Infections
  • Drug: Trizivir
    300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
    Other Name: TZV
  • 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
  • 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
  • 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.
    Intervention: Drug: Trizivir
  • 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.
    Interventions:
    • Drug: Lamivudine/Zidovudine
    • Drug: Lopinavir/Ritonavir
  • 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.
    Intervention: Drug: Nevirapine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
730
September 2010
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Botswana
 
 
NCT00270296
BHP 016
U01AI064002 ( US NIH Grant/Contract Award Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Harvard School of Public Health
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
National Institute of Allergy and Infectious Diseases (NIAID)
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP