HIV and cytomegalovirus viral load and clinical outcomes in AIDS and cytomegalovirus retinitis patients: Monoclonal Antibody Cytomegalovirus Retinitis Trial

Douglas Jabs, Adele M. Kaplan Gilpin, Yuan I. Min, Alejo Erice, John H. Kempen, Thomas C Quinn

Research output: Contribution to journalArticle

Abstract

Objective: To determine the association of cytomegalovirus (CMV) viremia with mortality and CMV retinitis progression in newly diagnosed and relapsed CMV retinitis. Design: Ancillary study of a randomized, placebo-controlled, phase III clinical trial. Patients: A total of 83 patients with AIDS and CMV retinitis, enrolled during the first phase of the Monoclonal Antibody Cytomegalovirus Retinitis Trial, were administered MSL-109 or placebo as adjuvant therapy for CMV retinitis. Main outcome measure(s): Mortality and CMV retinitis progression. Results: Treatment with MSL-109 did not predict either progression of CMV retinitis or mortality. Detection in plasma CMV DNA at baseline predicted mortality, but CMV antigenemia did not. CMV DNA was a better predictor of mortality than a high HIV viral load. Neither CMV DNA nor antigenemia predicted the progression of CMV retinitis. Among newly diagnosed patients, there was a decline in the proportion with detectable CMV viral load and CMV antigenemia in response to anti-CMV therapy. However, there was a rebound in CMV viral load to 25% and CMV antigenemia to 54.6% at 6 months. In relapsed patients, anti-CMV therapy was not associated with a change in the percentage with detectable CMV-DNA or CMV antigenemia over time. Conclusion: In patients with AIDS and CMV retinitis, the detection of plasma CMV DNA was associated with a higher risk of mortality than was a high HIV viral load. Anti-CMV therapy provided a transient reduction in CMV viremia in newly diagnosed but not relapsed patients with CMV retinitis. Adjuvant therapy with MSL-109 was ineffective in clearing CMV-DNA and CMV antigen from the plasma.

Original languageEnglish (US)
Pages (from-to)877-887
Number of pages11
JournalAIDS
Volume16
Issue number6
DOIs
StatePublished - Apr 12 2002

Fingerprint

Cytomegalovirus Retinitis
Viral Load
Cytomegalovirus
Acquired Immunodeficiency Syndrome
Monoclonal Antibodies
HIV
Mortality
DNA
Viremia
Therapeutics
Placebos

Keywords

  • AIDS
  • Antigenemia
  • Cytomegalovirus
  • HIV
  • Randomized clinical trial
  • Viral load
  • Viremia

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

HIV and cytomegalovirus viral load and clinical outcomes in AIDS and cytomegalovirus retinitis patients : Monoclonal Antibody Cytomegalovirus Retinitis Trial. / Jabs, Douglas; Kaplan Gilpin, Adele M.; Min, Yuan I.; Erice, Alejo; Kempen, John H.; Quinn, Thomas C.

In: AIDS, Vol. 16, No. 6, 12.04.2002, p. 877-887.

Research output: Contribution to journalArticle

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title = "HIV and cytomegalovirus viral load and clinical outcomes in AIDS and cytomegalovirus retinitis patients: Monoclonal Antibody Cytomegalovirus Retinitis Trial",
abstract = "Objective: To determine the association of cytomegalovirus (CMV) viremia with mortality and CMV retinitis progression in newly diagnosed and relapsed CMV retinitis. Design: Ancillary study of a randomized, placebo-controlled, phase III clinical trial. Patients: A total of 83 patients with AIDS and CMV retinitis, enrolled during the first phase of the Monoclonal Antibody Cytomegalovirus Retinitis Trial, were administered MSL-109 or placebo as adjuvant therapy for CMV retinitis. Main outcome measure(s): Mortality and CMV retinitis progression. Results: Treatment with MSL-109 did not predict either progression of CMV retinitis or mortality. Detection in plasma CMV DNA at baseline predicted mortality, but CMV antigenemia did not. CMV DNA was a better predictor of mortality than a high HIV viral load. Neither CMV DNA nor antigenemia predicted the progression of CMV retinitis. Among newly diagnosed patients, there was a decline in the proportion with detectable CMV viral load and CMV antigenemia in response to anti-CMV therapy. However, there was a rebound in CMV viral load to 25{\%} and CMV antigenemia to 54.6{\%} at 6 months. In relapsed patients, anti-CMV therapy was not associated with a change in the percentage with detectable CMV-DNA or CMV antigenemia over time. Conclusion: In patients with AIDS and CMV retinitis, the detection of plasma CMV DNA was associated with a higher risk of mortality than was a high HIV viral load. Anti-CMV therapy provided a transient reduction in CMV viremia in newly diagnosed but not relapsed patients with CMV retinitis. Adjuvant therapy with MSL-109 was ineffective in clearing CMV-DNA and CMV antigen from the plasma.",
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AB - Objective: To determine the association of cytomegalovirus (CMV) viremia with mortality and CMV retinitis progression in newly diagnosed and relapsed CMV retinitis. Design: Ancillary study of a randomized, placebo-controlled, phase III clinical trial. Patients: A total of 83 patients with AIDS and CMV retinitis, enrolled during the first phase of the Monoclonal Antibody Cytomegalovirus Retinitis Trial, were administered MSL-109 or placebo as adjuvant therapy for CMV retinitis. Main outcome measure(s): Mortality and CMV retinitis progression. Results: Treatment with MSL-109 did not predict either progression of CMV retinitis or mortality. Detection in plasma CMV DNA at baseline predicted mortality, but CMV antigenemia did not. CMV DNA was a better predictor of mortality than a high HIV viral load. Neither CMV DNA nor antigenemia predicted the progression of CMV retinitis. Among newly diagnosed patients, there was a decline in the proportion with detectable CMV viral load and CMV antigenemia in response to anti-CMV therapy. However, there was a rebound in CMV viral load to 25% and CMV antigenemia to 54.6% at 6 months. In relapsed patients, anti-CMV therapy was not associated with a change in the percentage with detectable CMV-DNA or CMV antigenemia over time. Conclusion: In patients with AIDS and CMV retinitis, the detection of plasma CMV DNA was associated with a higher risk of mortality than was a high HIV viral load. Anti-CMV therapy provided a transient reduction in CMV viremia in newly diagnosed but not relapsed patients with CMV retinitis. Adjuvant therapy with MSL-109 was ineffective in clearing CMV-DNA and CMV antigen from the plasma.

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