Clinical Study of an Aluvia-based HAART Regimen for Prevention of Mother-to-child HIV Transmission in Africa
Recruitment status was Active, not recruiting
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Purpose
Therapeutic options to prevent vertical transmission of HIV remain limited. Combination antiretroviral therapy in the form of HAART (Highly Active Anti Retroviral Therapy) is generally recommended in the developed world, both for its ability to reduce maternal viral load, and thus the likelihood of transmission, as well as for its prevention of drug resistance mutations, which might otherwise reduce future options for therapy in the mother, infant, or both. Exclusive formula-feeding is also recommended in the developed world (where clean water sources & adequate hygiene is reliably available) to prevent HIV transmission through breastmilk, however, this is not yet a feasible option in many developing world settings due to economic, infrastructure, social and infant-health reasons.
The investigators propose use of a HAART regimen during pregnancy and breastfeeding that is based upon the recently released Aluvia tablets (tablet form of LOPINAVIR/RITONAVIR or LOP; established capsule form is known as Kaletra) to improve maternal virological control and thus mother-to-child-transmission (MTCT).
Hypothesis: Maternal use of HAART containing Zidovudine, 3TC and Aluvia (Lopinavir/Ritonavir) can prevent antepartum, and intrapartum transmission of HIV, as well as allow exclusive and then subsequent complementary feeding to be carried out with minimum risk to the mother and infant.
- Study regimen: ZDV/3TC (combivir) + 2 Aluvia Tabs all PO BID to start at 14-30 weeks gestational age (GA) and continue through labor and as long as the mother breastfeeds
- Peripartum single dose Nevirapine (sdNVP) (Note: Mothers will also be receiving ZDV as part of the study regimen) to mother and sdNVP + 5 days postpartum ZDV to the infant will be given as per current Zambian practice
- Exclusive breastfeeding (EBF) x 6 months then complementary foods to be added, with aim for a gradual wean of breastfeeding by infant age of 12-13 months. In case of inability to wean by 13 months, however, drug will be continued until the mother has achieved a complete wean.
- Follow-up period: Mother & child will be followed to an infant age of 24 months, as per schedule-of-visits (approx every 3 months)
Major outcome measure: infant survival and negative dbs (dried blood spot) PCR 3 months post weaning.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TC |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Use of an Aluvia Based Highly Active Antiretroviral Therapy (HAART) Regimen in the Prevention of Mother to Child HIV Transmission (PMTCT) Antepartum, Intrapartum and Postpartum in Africa |
- HIV Negative Survival of Infants [ Time Frame: to be assessed at: infant age 6 months, 3 months post-weaning from breastfeeding, infant/child age 24 months ] [ Designated as safety issue: Yes ]
- Maternal survival, viral suppression and CD4 response [ Time Frame: End-of-Study (Infant actual/predicted age 18-24 months) ] [ Designated as safety issue: Yes ]
- Emergence of viral drug resistance in mothers or infants [ Time Frame: End-of-Study (infant actual/predicted age 18-24 months) ] [ Designated as safety issue: No ]
- Incidence of diarrhea, malnutrition/growth failure and pneumonia in infants [ Time Frame: Infant actual/predicted age 1 year and 18-24 months ] [ Designated as safety issue: No ]
- Cost-effectiveness analysis [ Time Frame: End-of-Study (infant actual/predicted age 24 months) ] [ Designated as safety issue: No ]
- Efficacy of therapy in prevention of transmission with supplemental feeding among those infants who remain PCR negative at 6 months of age [ Time Frame: Infant age 6 months and 3-months post-wean ] [ Designated as safety issue: No ]
| Enrollment: | 280 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aluvia-based HAART
Study regimen: ZDV/3TC (combivir) + 2 Aluvia Tabs all PO BID to start at 14-30 weeks gestational age (GA) and continue through labor and as long as the mother breastfeeds
|
Drug: Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TC
Zidovudine 300mg PO BID + 3TC 150 mg PO BID + Lopinavir/Ritonavir (200/50 mg) two tablets PO BID
Other Names:
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Minimum age 15 years
- Pregnancy and ability to initiate therapy between 14-30 weeks gestation
- HIV seropositivity
- Intention to exclusively breastfeed for 6 months
- Ability to give informed consent
- Ability to attend follow-up visits
Exclusion Criteria:
- Previous HAART
- Pre-existing known major illnesses likely to influence pregnancy outcome or place participant at increased risk from adverse events from HAART therapy, including diabetes, severe renal, liver or heart disease, or active tuberculosis
- Severe anemia (Hemoglobin <8 gm/dL)
- Current and continuing therapy with selected medications which are either absolutely or relatively contraindicated for co-administration with Aluvia
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Michael Silverman, University of Toronto |
| ClinicalTrials.gov Identifier: | NCT01088516 History of Changes |
| Other Study ID Numbers: | Aluvia Breastfeeding Study, A10-324 |
| Study First Received: | January 25, 2010 |
| Last Updated: | March 16, 2010 |
| Health Authority: | Canada: Ethics Review Committee Zambia: Ministry of Health Zambia: Pharmaceutical Regulatory Authority Zambia: Research Ethics Committee |
Keywords provided by University of Zambia:
|
Human Immunodeficiency Virus Vertical Transmission Pregnancy Breastfeeding Prevention of mother to child transmission |
HAART Aluvia Lopinavir Africa Infectious Disease Transmission, Vertical |
Additional relevant MeSH terms:
|
Zidovudine Lamivudine Lamivudine, zidovudine drug combination Ritonavir Lopinavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors |
ClinicalTrials.gov processed this record on March 14, 2013
