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.

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When to Initiate Therapy in Antiretroviral-Naive Children

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

Panel’s Recommendations on When to Initiate Therapy in Antiretroviral-Naive Children
Panel’s Recommendations
  • Antiretroviral therapy (ART) should be initiated in all infants and children with HIV infection (AI for children aged <3 months, AI* for older children).
    • Rapid ART initiation (defined as initiating ART immediately or within days of diagnosis), accompanied by a discussion of the importance of adherence and provision of subsequent adherence support, is recommended for all children with HIV.
  • If a child with HIV has not initiated ART, health care providers should closely monitor the virologic, immunologic, and clinical status at least every 3 to 4 months (AIII).
Rating of Recommendations: A = Strong; B = Moderate; C = Optional

Rating of Evidence: I = One or more randomized trials in children with 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 children from 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 5: HIV Infection Stage Based on Age-Specific CD4 Cell Count or Percentage
Stagea Aged <1 Year Aged 1 Year to <6 Years Aged ≥6 Years
Cells/mm3  % Cells/mm3  % Cells/mm3  %
1 ≥1,500  ≥34 ≥1,000  ≥30 ≥500  ≥26
2 750–1,499  26–33 500–999  22–29 200–499  14–25
3 <750  <26 <500  <22 <200  <14
a The stage is based primarily on the CD4 count; the CD4 count takes precedence over the CD4 percentage, and the percentage is considered only when the count is missing. If a Stage 3-defining condition has been diagnosed (see Table 6), then the stage is 3 regardless of CD4 test results.

Source: Centers for Disease Control and Prevention. Revised surveillance case definition for HIV infection—United States, 2014. MMWR 2014;63(No. RR-3):1-10.

Key: CD4 = CD4 T lymphocyte

Table 6. HIV-Related Symptoms and Conditions
Mildly Symptomatic
Children with two or more of the following conditions, but none of the conditions listed in the Moderately Symptomatic category, are considered mildly symptomatic:
  • Lymphadenopathy (lymph nodes are ≥0.5 cm at more than two sites and/or bilateral at one site)
  • Hepatomegaly
  • Splenomegaly
  • Dermatitis
  • Parotitis
  • Recurrent or persistent upper respiratory tract infection, sinusitis, or otitis media
Moderately Symptomatic
  • Anemia (hemoglobin <8 g/dL [<80 g/L]), neutropenia (white blood cell count <1,000 per µL [<1.0 × 109 per L]), and/or thrombocytopenia (platelet count <100 × 103 per µL [<100 × 109 per L]) persisting for ≥30 days
  • Bacterial meningitis, pneumonia, or sepsis (single episode)
  • Candidiasis, oropharyngeal (thrush), persisting for >2 months in children aged >6 months
  • Cardiomyopathy
  • CMV infection, with onset before age 1 month
  • Diarrhea, recurrent or chronic
  • Hepatitis
  • HSV stomatitis, recurrent (more than two episodes within 1 year)
  • HSV bronchitis, pneumonitis, or esophagitis with onset before age 1 month
  • Herpes zoster (shingles) involving at least two distinct episodes or more than one dermatome
  • Leiomyosarcoma
  • Lymphoid interstitial pneumonia or pulmonary lymphoid hyperplasia complex
  • Nephropathy
  • Nocardiosis
  • Persistent fever (lasting >1 month)
  • Toxoplasmosis, onset before age 1 month
  • Varicella, disseminated (complicated chickenpox)
AIDS-Defining Conditions
  • Bacterial infections, multiple or recurrenta
  • Candidiasis of bronchi, trachea, or lungs
  • Candidiasis of esophagus
  • Cervical cancer, invasive
  • Coccidioidomycosis, disseminated or extrapulmonary
  • Cryptococcosis, extrapulmonary
  • Cryptosporidiosis, chronic intestinal (>1 month duration)
  • CMV disease (other than liver, spleen, or lymph nodes), onset at age >1 month
  • CMV retinitis (with loss of vision)
  • Encephalopathy attributed to HIVb
  • HSV: chronic ulcers (>1 month duration) or bronchitis, pneumonitis, or esophagitis (onset at age >1 month)
  • Histoplasmosis, disseminated or extrapulmonary
  • Isosporiasis, chronic intestinal (>1 month duration)
  • Kaposi sarcoma
  • Lymphoma, Burkitt (or equivalent term)
  • Lymphoma, immunoblastic (or equivalent term)
  • Lymphoma, primary, of brain
  • Mycobacterium avium complex or Mycobacterium kansasii, disseminated or extrapulmonary
  • Mycobacterium tuberculosis of any site, pulmonary, disseminated, or extrapulmonary
  • Mycobacterium, other species or unidentified species, disseminated or extrapulmonary
  • Pneumocystis jirovecii (previously known as Pneumocystis carinii) pneumonia
  • Pneumonia, recurrentc
  • Progressive multifocal leukoencephalopathy
  • Salmonella septicemia, recurrent
  • Toxoplasmosis of brain, onset at age >1 month
  • Wasting syndrome attributed to HIVb
a Only among children aged <6 years.
b Suggested diagnostic criteria for these illnesses, which might be particularly important for HIV encephalopathy and HIV wasting syndrome, are described in the following references:

Centers for Disease Control and Prevention. 1994 Revised classification system for human immunodeficiency virus infection in children less than 13 years of age. MMWR. 1994;43(No. RR-12).

Centers for Disease Control and Prevention. 1993 Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR. 1992;41(No. RR-17).

c Only among adults, adolescents, and children aged ≥6 years. 

Key: CMV = cytomegalovirus; HSV = herpes simplex virus

Modified from:

Centers for Disease Control and Prevention. 1994 revised classification system for human immunodeficiency virus infection in children less than 13 years of age. MMWR. 1994;43(No. RR-12).

Centers for Disease Control and Prevention: Revised Surveillance Case Definition for HIV Infection—United States, 2014. MMWR. 2014;63(No. RR-3):1-10.

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