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

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ClinicalTrials.gov Identifier: NCT01088516
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : June 24, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
HIV Drug: Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TC Phase 4

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


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2008
Primary Completion Date : November 2011
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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:
  • Combivir (Zidovudine or AZT + 3TC)
  • Aluvia (Lopinavir/Ritonavir)


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Maternal survival, viral suppression and CD4 response [ Time Frame: End-of-Study (Infant actual/predicted age 18-24 months) ]
  2. Emergence of viral drug resistance in mothers or infants [ Time Frame: End-of-Study (infant actual/predicted age 18-24 months) ]
  3. Incidence of diarrhea, malnutrition/growth failure and pneumonia in infants [ Time Frame: Infant actual/predicted age 1 year and 18-24 months ]
  4. Cost-effectiveness analysis [ Time Frame: End-of-Study (infant actual/predicted age 24 months) ]
  5. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088516


Locations
Zambia
Chelstone Clinic
Lusaka, Zambia
Sponsors and Collaborators
University of Zambia
University of Toronto
Abbott
Investigators
Principal Investigator: Michael Silverman, MD University of Toronto
More Information

Responsible Party: Dr Michael Silverman, Chair of Infectious Diseases, St.Joseph's Hospital, London, Ontario, Canada, University of Zambia
ClinicalTrials.gov Identifier: NCT01088516     History of Changes
Other Study ID Numbers: Aluvia Breastfeeding Study
A10-324 ( Other Grant/Funding Number: Abbott )
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by Dr Michael Silverman, 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:
Ritonavir
Lopinavir
Zidovudine
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
Antimetabolites
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors