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Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV
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Purpose
| 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 |
- 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:
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00270296
| 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 | |
| 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 August 21, 2017