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

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Trizivir; Drug: Lamivudine/Zidovudine; Drug: Nevirapine; Drug: Lopinavir/Ritonavir

• Registration Number: NCT00270296
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2005-12-22
• Study First Submitted QC: 2005-12-22
• Study First Posted: 2005-12-26
• Study Start: 2006-06
• Primary Completion: 2009-03
• Disposition First Submitted: 2010-03-26
• Disposition First Submitted QC: 2010-03-26
• Disposition First Posted: 2010-03-30
• Study Completion: 2010-09
• Results First Submitted: 2017-03-14
• Results First Submitted QC: 2017-04-27
• Results First Posted: 2017-06-05
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 730

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trizivir (TZV) Arm	Trizivir	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.
Kaletra Arm	Lamivudine/Zidovudine	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.
Kaletra Arm	Lopinavir/Ritonavir	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.
Nevirapine (NVP) Arm	Nevirapine	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Virologic Suppression	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	Throughout study, including breastfeeding, assessed up to 24 months	Number of infants with HIV-positive status

Trial Locations

Locations (4)

Athlone Hosp., BHP Study Clinic, Lobatse Shapiro CRS; 🇧🇼 Lobatse, Botswana

Princess Marina Hosp., BHP Study Clinic, Gaborone Shapiro CRS; 🇧🇼 Gaborone, Botswana

Deborah Reteif Hosp., BHP Study Clinic, Mochudi Shapiro CRS; 🇧🇼 Mochudi, Botswana

Scottish Livingstone Hosp., BHP Study Clinic, Molepolole Shapiro CRS; 🇧🇼 Molepolole, Botswana