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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Zambia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Toronto
Abbott
Information provided by:
University of Zambia
ClinicalTrials.gov Identifier:
NCT01088516
First received: January 25, 2010
Last updated: March 16, 2010
Last verified: January 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Zambia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:
  • Combivir (Zidovudine or AZT + 3TC)
  • Aluvia (Lopinavir/Ritonavir)

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 August 28, 2014