Human Immunodeficiency Virus Type 1 RNA Level and CD4 Count as Prognostic Markers and Surrogate End Points: A Meta-Analysis

ABSTRACT Treatments for human immunodeficiency virus type 1 (HIV-1)-positive individuals that augment HIV-1 suppression and have potential for achieving long-term control of HIV-1 viremia in the absence of antiretroviral therapy (ART) are urgently needed. We therefore conducted a phase I, clinical safety trial of a dendritic cell (DC)-based vaccination strategy as immunotherapy for HIV-1-positive individuals on ART. We studied 18 HIV-1-positive subjects on ART who underwent leukapheresis to obtain peripheral blood mononuclear cells for DC generation from monocytes cultured with cytokines. Mature DC were pulsed with three HIV-1 HLA*A0201 Gag, Env, and Pol peptides and one influenza A virus matrix protein peptide. The vaccine was administered to donors randomized to receive two vaccinations, either intravenously or subcutaneously. The primary end points were safety and tolerability of two doses of peptide-DC vaccine (3 million versus 10 million). Secondary end points included gamma interferon (IFN-γ) enzyme-linked immunospot assay responses and clinical correlates of an immune response to vaccination. Autologous DC-peptide vaccine was safe, well tolerated, and feasible for use in all participants. Adverse events were rare. Although the trial was not powered to assess an immunologic response, a significantly increased frequency of HIV-1 peptide-specific IFN-γ-positive cells was observed 2 weeks following the second vaccine, with three individuals responding to all four peptides. DC vaccination was safe, was feasible, and showed promise of immunogenicity in ART-treated, HIV-1-positive individuals. Additional studies of DC immunization strategies for HIV-1 infection are warranted.

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Meta-analysis and systematic review of the efficacy and resistance for human immunodeficiency virus type 1 integrase strand transfer inhibitors

International Journal of Antimicrobial Agents ◽

10.1016/j.ijantimicag.2019.08.008 ◽

2019 ◽

Vol 54 (5) ◽

pp. 547-555 ◽

Cited By ~ 7

Author(s):

Li-Li Yang ◽

Qi Li ◽

Li-Bo Zhou ◽

Shu-Qing Chen

Keyword(s):

Systematic Review ◽

Human Immunodeficiency Virus ◽

Human Immunodeficiency Virus Type ◽

Virus Type ◽

Meta Analysis ◽

Strand Transfer ◽

Immunodeficiency Virus ◽

Integrase Strand Transfer Inhibitors

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The Impact of Human Immunodeficiency Virus Type 1 on Infectiousness of Tuberculosis: A Meta‐Analysis

Clinical Infectious Diseases ◽

10.1086/324352 ◽

2001 ◽

Vol 33 (11) ◽

pp. 1922-1930 ◽

Cited By ~ 52

Author(s):

Mario Cruciani ◽

Marina Malena ◽

Oliviero Bosco ◽

Giorgio Gatti ◽

Giovanni Serpelloni

Keyword(s):

Human Immunodeficiency Virus ◽

Human Immunodeficiency Virus Type ◽

Virus Type ◽

Meta Analysis ◽

Immunodeficiency Virus ◽

The Impact

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Evaluation of TruCount Absolute-Count Tubes for Determining CD4 and CD8 Cell Numbers in Human Immunodeficiency Virus-Positive Adults

Clinical and Diagnostic Laboratory Immunology ◽

10.1128/cdli.7.3.336-343.2000 ◽

2000 ◽

Vol 7 (3) ◽

pp. 336-343 ◽

Cited By ~ 50

Author(s):

Carol T. Schnizlein-Bick ◽

John Spritzler ◽

Cynthia L. Wilkening ◽

Janet K. A. Nicholson ◽

Maurice R. G. O'Gorman

Keyword(s):

Human Immunodeficiency Virus ◽

Human Immunodeficiency Virus Type ◽

Virus Type ◽

Cd4 Count ◽

Cd4 Cells ◽

Absolute Count ◽

Individual Site ◽

Immunodeficiency Virus ◽

Count Change

ABSTRACT A single-platform technology that uses an internal bead standard and three-color flow cytometry to determine CD4 and CD8 absolute counts was evaluated for reproducibility and agreement. Values obtained using TruCount absolute-count tubes were compared to those obtained using a two-color predicate methodology. Sixty specimens from human immunodeficiency virus type 1-infected donors were shipped to five laboratories. Each site also analyzed replicates of 14 human immunodeficiency virus type 1-infected local specimens at 6 h and again at 24 h. The interlaboratory variability was significantly less with TruCount (median difference in percent coefficient of variation [%CV] between the two methods was −8% and −3% for CD4 and CD8, respectively) than with the predicate method. Intralaboratory variability was smaller, with a median difference in %CV of −1% for both CD4 and CD8 with 6-h samples and −2% and −3% for CD4 and CD8, respectively, with 24-h samples. Use of TruCount for shipped samples resulted in a median CD4 count change of 7 cells (50th estimated percentile) when all laboratories and CD4 strata were combined. For on-site samples, the median CD4 count change was 10 CD4 cells for 6-h samples and 2 CD4 cells for 24-h samples. Individual site biases occurred in both directions and cancelled each other when the data were combined for all laboratories. Thus, the combined data showed a smaller change in median CD4 count than what may have occurred at an individual site. In summary, the use of TruCount decreased both the inter- and intralaboratory variability in determining absolute CD4 and CD8 counts.

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Usefulness of Alternate Prognostic Serum and Plasma Markers for Antiretroviral Therapy for Human Immunodeficiency Virus Type 1 Infection

Clinical and Vaccine Immunology ◽

10.1128/cvi.00193-07 ◽

2007 ◽

Vol 15 (1) ◽

pp. 154-158 ◽

Cited By ~ 10

Author(s):

R. Kannangai ◽

A. J. Kandathil ◽

D. L. Ebenezer ◽

E. Mathai ◽

A. J. Prakash ◽

...

Keyword(s):

Human Immunodeficiency Virus ◽

T Cell ◽

Human Immunodeficiency Virus Type ◽

Virus Type ◽

Prognostic Markers ◽

Immunodeficiency Virus ◽

Before And After ◽

Hiv 1 ◽

Plasma Markers

ABSTRACT In developing countries, the usability of peripheral blood constituents that are low-cost alternatives to CD4-positive (CD4+) T-cell and human immunodeficiency virus type 1 (HIV-1) RNA estimation should be evaluated as prognostic markers. The aim of our study was to investigate the use of plasma levels of dehydroepiandrosterone sulfate (DHEAS), albumin, and C-reactive protein (CRP) as alternate prognostic markers for antiretroviral treatment (ART) response in place of HIV-1 load measurements. Paired blood samples were collected from 30 HIV-infected individuals before and after initiation of ART, 13 HIV-infected individuals before and after completion of antituberculosis therapy (ATT), and 10 HIV-infected individuals not on either ATT or ART. Because of the nonavailability of samples, the CRP estimation was done for samples from only 19, 9, and 8 individuals in groups 1, 2, and 3, respectively. The measurements of all three markers, i.e., DHEAS, albumin, and CRP, were carried out with commercial assays. The differences in the albumin levels before and after ART or ATT were significant (P < 0.05), while the differences in DHEAS and CRP levels were not significant (P > 0.05). When levels of DHEAS among the individuals who were followed up were analyzed, 13 (44.8%) in the ART group and 9 (69%) in the ATT group showed an increase following treatment. Prior to treatment of HIV-infected individuals, there was a significant positive correlation of CD4+ T-cell counts and a negative correlation of viral load with albumin and DHEAS levels (P < 0.01). Among the three plasma markers we tested, plasma albumin and, to some extent, DHEAS show promise as prognostic markers in monitoring HIV infection.

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