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.

• Authors: Douglas A Jabs, Adele M Kaplan Gilpin, Yuan-I Min, Alejo Erice, John H Kempen, Thomas C Quinn, Studies of Ocular Complications of AIDS Research Group
• Journal: AIDS (London, England) (AIDS) Vol. 16 Issue 6 Pg. 877-87 (Apr 12 2002) ISSN: 0269-9370 [Print] England
• PMID: 11919489 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antibodies, Monoclonal
• Antigens, Viral
• DNA, Viral
• Placebos
• sevirumab

Topics

• AIDS-Related Opportunistic Infections (complications, therapy, virology)
• Adult
• Antibodies, Monoclonal (therapeutic use)
• Antigens, Viral (blood)
• Cytomegalovirus (genetics, immunology, isolation & purification)
• Cytomegalovirus Retinitis (complications, therapy, virology)
• DNA, Viral (blood)
• Female
• Humans
• Male
• Placebos
• Treatment Outcome
• Viral Load