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Completed

NCT Number: NCT02431975

Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial

The investigators propose a non-randomized clinical trial of 60 HIV-infected infants identified within 48 hours of birth and their mothers to investigate the consequences of very early ART on the establishment and maintenance of the viral reservoir.

The first phase (early ART initiation within 48 hours of birth) will examine the trajectory i.e. changes over time of the viral reservoir and detection of HIV-specific antibody responses in infants testing HIV-positive within 48 hours of birth and initiating early ART.

Secondary pathogenesis aims will test whether markers of neonatal immune quiescence are associated with the extent of seeding and rate of decline of the viral reservoir when ART is started at a young age and investigate whether markers in infant stool samples can be used as a non-invasive method of defining relevant immune and HIV-specific parameters associated with viral reservoir size.

The investigators hypothesize that developmental characteristics of newborn immunity may make this period the optimal time to begin ART and influence the seeding of the viral reservoir.

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Key information

Conditions

HIV

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rahima Moosa Mother and Child Hospital

Johannesburg, Gauteng, South Africa

About this study

Prevention of mother-to-child transmission (PMTCT) programs using antiretrovirals (ARVs) have had tremendous success in sub-Saharan Africa. However, HIV transmission continues to occur because (1) implementation of PMTCT is incomplete and (2) ARV interventions are not 100% effective in blocking infection. Thus the challenge of providing treatment to HIV-infected children is far from over. The capacity of early ART treatment to favorably influence the viral reservoir and potentially lead to post-treatment cessation viral control needs to be described in the population of infants, and to identify useful public health strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Point of care (POC) or laboratory-based test positive on a sample collected within 48 hours of birth.
  • Mother willing and able to provide informed consent.

Exclusion criteria

  • Expressed intention to leave the Johannesburg area permanently.
  • Co-morbidities, birth defects or other conditions which in the opinion of the clinical team have a greater than 50% risk of mortality in the first days of life.
  • Co-morbidities or conditions which in the opinion of the clinical team advise against initiation of ART within the first 48 hours of life.
  • Active (uncontrolled) maternal psychiatric illness.

Treatment and study plan

Nevirapine

Drug

Standard medication used to treat and prevent HIV/AIDS, specifically HIV-1. It is generally recommended for use with other antiretroviral medication.

The initial dose of NVP will be 6 mg per kg per dose orally twice daily until 42 weeks gestational age (2 weeks of age for infants born at term) which is the dosing selected by the NIH International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Network.

Other names: NVP, Viramune

Zidovudine

Drug

An antiretroviral medication used to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretroviral.

ZDV will be dosed as per standard guideline and routine practices.

Other names: ZDV, Retrovir

Lamivudine

Drug

An antiretroviral medication used to prevent and treat HIV/AIDS. It is effective against both HIV-1 and HIV-2.

3TC will be dosed as per standard guideline and routine practices.

Other names: 3TC, Epivir

LPV/r

Drug

Lopinavir is an antiretroviral of the protease inhibitor class. It is used against HIV infections as a fixed-dose combination with another protease inhibitor, ritonavir.

LPV/r will be dosed as per standard guideline and routine practices.

Other names: Ritonavir-boosted lopinavir

Primary outcomes

  1. Percent of patients with initial viral suppression

    Time frame: 24 weeks

    Suppression is defined as patients with plasma HIV RNA <50 copies/mL.

Secondary outcomes

  1. Percent of patients maintaining viral suppression

    Time frame: Between 24 and104 weeks

    Suppression is defined as patients with plasma HIV RNA <50 copies/mL.

  2. Prevalence of CD4 percentage greater than 30

    Time frame: By 24 weeks and sustained through 104 weeks

    Patients that reached a normal CD4% level.

  3. Prevalence of growth along curve within one standard deviation or upward trend

    Time frame: Up to 104 weeks

    By comparing viral growth curves.

  4. Prevalence of detection of specific HIV antibody classes

    Time frame: 24 and 104 weeks

    HIV antibody detection

  5. Size of the viral reservoir (copies/million cell)

    Time frame: Up to 104 weeks

    Quantification of viral reservoir

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)
  • University of Witwatersrand, South Africa

Registry information

Acronym: LEOPARD

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
May 1, 2015
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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