Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

  •   Table of Contents

Download Guidelines

Clinical and Laboratory Monitoring of Pediatric HIV Infection

Last Updated: April 14, 2020; Last Reviewed: April 14, 2020

Panel's Recommendations for Clinical and Laboratory Monitoring of Pediatric HIV Infection
Panel's Recommendations
  • Absolute CD4 T lymphocyte (CD4) cell count and plasma HIV RNA (viral load) should be measured at the time of HIV diagnosis and, if a child is not started on antiretroviral therapy (ART) after diagnosis, this monitoring should be repeated at least every 3 to 4 months thereafter (AIII).
  • Absolute CD4 count is recommended for monitoring immune status in children of all ages, with CD4 percentage as an alternative for children aged <5 years (AII).
  • Antiretroviral (ARV) drug-resistance testing is recommended at the time of HIV diagnosis, before initiation of therapy, in all ART-naive patients (AII). Genotypic resistance testing is preferred for this purpose (AIII).
  • After initiation of ART, or after a change in ARV regimen, children should be evaluated for clinical adverse effects and should receive support for treatment adherence within 1 to 2 weeks; laboratory testing for toxicity and viral load response is recommended at 2 to 4 weeks after treatment initiation (AIII).
  • Children on ART should be monitored for therapy adherence, effectiveness, and toxicities routinely (every 3–4 months) (AII*).
  • Additional CD4 count and plasma viral load monitoring should be performed to evaluate children with suspected clinical, immunologic, or virologic deterioration or to confirm an abnormal value (AIII). CD4 count can be monitored less frequently (every 6–12 months) in children and adolescents who are adherent to therapy, who have sustained virologic suppression and CD4 count values that are well above the threshold for opportunistic infection risk, and who have stable clinical status (AII). Viral load measurement every 3 to 4 months is generally recommended to monitor ART adherence and disease progression (AIII).
  • Phenotypic resistance testing should be considered (usually in addition to genotypic resistance testing) for patients with known or suspected complex drug resistance mutation patterns, which generally arise after a patient has experienced virologic failure on multiple ARV regimens (CIII).
  • The absence of detectable resistance to a drug does not ensure that use of the drug will be successful, as mutations may not be detected once the drug has been discontinued. A history of all previously used ARV agents and available resistance test results must be reviewed when making decisions regarding the choice of new ARV agents (AII).
  • Viral co-receptor tropism assays are recommended whenever a CCR5 antagonist is being considered for treatment (AI*). The use of tropism assays should also be considered for patients who demonstrate virologic failure while receiving therapy that contains a CCR5 antagonist (AI*).
Rating of Recommendations: A = Strong; B = Moderate; C = Optional

Rating of Evidence: I = One or more randomized trials in childrenwith clinical outcomes and/or validated endpoints; I* = One or more randomized trials in adults with clinical outcomes and/or validated laboratory endpoints with accompanying data in childrenfrom one or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; II = One or more well-designed, nonrandomized trials or observational cohort studies in children with long-term outcomes; II* = One or more well-designed, nonrandomized trials or observational studies in adults with long-term clinical outcomes with accompanying data in children from one or more similar nonrandomized trials or cohort studies with clinical outcome data; III = Expert opinion

Studies that include children or children/adolescents, but not studies limited to post-pubertal adolescents

Table 4. Primary Food and Drug Administration-Approved Assays for Monitoring Viral Load
Assay Abbott Real Time NucliSens EasyQ v2.0 COBAS AmpliPrep/TaqMan v2.0 Versant v1.0 Aptima HIV-1 Quant Assay 
Method Real-time RT-PCR Real-time NASBA Real-time RT-PCR Real-time RT-PCR Real-time TMA
Dynamic Range 40–107 copies/mL 25–107 copies/mL 20–107 copies/mL 37–11x107 copies/mL 30–107 copies/mL
Specimen Volumea 0.2–1 mL 0.1–1 mL 1 mL 0.5 mL ≥0.4 mL
Manufacturer Abbott Laborotories bioMerieux Roche Siemens Hologic, Inc.
a Smaller volumes for children can be accommodated.

Key: NASBA = nucleic acid sequence-based amplification; RT-PCR = reverse transcription polymerase chain reaction; TMA = transcription-mediated amplification

Download Guidelines