Clinical Study of an Aluvia-based HAART Regimen for Prevention of Mother-to-child HIV Transmission in Africa

NCT ID: NCT01088516

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-05-31

Brief Summary

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.

Detailed Description

Study completed. Results are being published and the manuscript is in press as of June 2015

Ngoma MS, Misir A, Mutale W, Rampakakis E, Sampalis JS, Elong A, Chisele S, Mwale A, Mwansa JK, Mumba S, Chandwe M, Pilon R, Sandstrom P, Wu S, Yee K and Silverman MS. Efficacy of WHO recommendation for continued breastfeeding and maternal cART for prevention of perinatal and postnatal HIV transmission in Zambia. Journal of the International AIDS Society; 2015

Conditions

HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TC

Intervention Type: DRUG

Zidovudine 300mg PO BID + 3TC 150 mg PO BID + Lopinavir/Ritonavir (200/50 mg) two tablets PO BID

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Combivir (Zidovudine or AZT + 3TC); Aluvia (Lopinavir/Ritonavir)

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Toronto

OTHER

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: collaborator

University of Zambia

OTHER

Sponsor Role: lead

Responsible Party

Dr Michael Silverman

Chair of Infectious Diseases, St.Joseph's Hospital, London, Ontario, Canada

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Silverman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Chelstone Clinic

Lusaka, , Zambia

Countries

Zambia

Other Identifiers

A10-324

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Aluvia Breastfeeding Study

Identifier Type: -

Identifier Source: org_study_id