L. specificities. After 1 year of age, Ab levels to p31 and p17 were significantly associated with HIV-1 RNA levels (P< .001); Ab levels to gp160 (P< .001) and gp41 (P< .001) were significantly associated with cell-associated HIV-1 DNA levels. == Conclusions == Quantitative HIV-1specific Ab levels Inosine pranobex may be useful for screening children on ART for viral suppression or for residual, cell-associated HIV-1 DNA levels. == Clinical Trials Registration == NCT00000872. Keywords:pediatric early antiretroviral therapy, HIV-1 persistence, HIV-1 quantitative antibodies Quantitative human immunodeficiency computer virus (HIV)-1specific antibody Rabbit Polyclonal to Cytochrome P450 2A6 levels are associated with plasma HIV-1 RNA and cell-associated HIV-1 DNA levels in children on antiretroviral therapy and may be useful for identifying children with viral suppression and low residual HIV-1 DNA levels. Combination antiretroviral therapy (ART) markedly reduces human immunodeficiency computer virus (HIV)-1related morbidity and mortality in children [1]. Early ART initiation in children prior to 36 months of age can be particularly effective for long-term control of HIV-1 replication, preserving immune functions [2,3], reducing HIV-1related illnesses and mortality [4], and limiting residual HIV-1 reservoirs [5,6]. International treatment guidelines [79] now recommend ART initiation in HIV-1infected children as soon as possible after birth. Methods for quantifying plasma HIV-1 RNA and peripheral blood mononuclear cell (PBMC)-associated HIV-1 DNA in children following ART are expensive and logistically challenging, particularly for implementation in limited-resource settings. We [10] and others [1113] have previously shown that children who achieve durable suppression of HIV-1 replication after early (<3 months) ART have very low levels of PBMC-associated HIV-1 DNA, and the majority lack persistent HIV-1 immunoglobulin G (IgG) antibodies [3,14]. Children who initiate treatment after 36 months of age have higher levels of PBMC-associated HIV-1 DNA and remain HIV-1antibody (Ab) positive. In a prior cross-sectional study, children with negative or indeterminate Western blots had lower levels of circulating HIV-1 DNA than those with positive Western blots [15]. We therefore undertook this study to further evaluate the utility of using Inosine pranobex quantitative HIV-1 Ab levels to HIV-1 proteins as a screening method for virologic suppression and residual PBMC-associated HIV-1 DNA in children on therapy. The quantitation of Ab levels to selected HIV-1 proteins prior to and sequentially up to 4 years following ART allowed for the calculation of Ab clearance rates and the development of models that used specific Ab levels to predict the likelihood of undetectable plasma HIV-1 RNA or the level of circulating, PBMC-associated HIV-1 DNA. == METHODS == == Study Cohort == The study cohort included 46 HIV-1infected children, stratified by timing of ART initiation (early therapy [ET] <3 months of age; late therapy [LT] >3 months to 2 years of age) and as virologic responders (R) or non-responders (NR). There were 44 children that received ART through an open-label, phase I/II clinical trial that evaluated the pharmacokinetics, safety, and antiviral activity of combination antiviral therapies initiated under 2 years of age Inosine pranobex (Pediatric AIDS Clinical Trials Group Protocol [PACTG] 356; clinical trialsNCT00000872[16]); 2 were treated by open prescription. Specimens were collected from HIV-1infected participants from 1995 through 2005 at clinical sites throughout the United States and Puerto Rico. Virologic responders were defined as HIV-1infected children who achieved plasma HIV-1 RNA levels of <400 copies/ml by 48 weeks of therapy and sustained plasma HIV-1 RNA <50 copies/ml through at least 96 weeks; 4 children who were classified as responders experienced a viral rebound (RNA > 50 copies/ml) and 1 child experienced a viral blip (a single value of 106 copies/ml) after 96 weeks on ART. Ab decline estimates in virologic responders were calculated from samples obtained prior to 96 weeks of study. Virologic non-responders (NR: 10 ET and 14 LT).