Diagnosis of Primary HIV-1 Infection

  1. Eric S. Daar, MD;
  2. Susan Little, MD;
  3. Jacqui Pitt, RN;
  4. Joanne Santangelo, NP;
  5. Pauline Ho, MD;
  6. Nina Harawa, MPH;
  7. Peter Kerndt, MD;
  8. Janis V. Giorgi, PhD;
  9. Jiexin Bai, MD;
  10. Paula Gaut, MD;
  11. Douglas D. Richman, MD;
  12. Susan Mandel, MD;
  13. Stephen Nichols, MD; and
  14. for the Los Angeles County Primary HIV Infection Recruitment Network*
  1. From Cedars-Sinai Burns & Allen Research Institute, University of California, Los Angeles, School of Medicine, Los Angeles County HIV Epidemiology Program, University of California, Los Angeles, Center for AIDS Research, and Los Angeles Free Clinic, Los Angeles, California; and University of California, San Diego, and San Diego Veterans Affairs Healthcare System, San Diego, California.

    Abstract

    Background: The optimal approach for diagnosing primary HIV-1 infection has not been defined.

    Objective: To determine the usefulness of symptoms and virologic tests for diagnosing primary HIV-1 infection.

    Design: Prospective cohort study.

    Setting: A teaching hospital in Los Angeles and a university research center in San Diego, California.

    Patients: 436 patients who had symptoms consistent with primary HIV infection.

    Measurements: Clinical information and levels of HIV antibody, HIV RNA, and p24 antigen.

    Results: Primary infection was diagnosed in 54 patients (12.4%). The sensitivity and specificity of the p24 antigen assay were 88.7% (95% CI, 77.0% to 95.7%) and 100% (CI, 99.3% to 100%), respectively. For the HIV RNA assay, sensitivity was 100% and specificity was 97.4% (CI, 94.9% to 98.9%). Fever, myalgia, rash, night sweats, and arthralgia occurred more frequently in patients with primary infection (P < 0.05).

    Conclusions: No sign or symptom allows targeted screening for primary infection. Although assays for HIV RNA are more sensitive than those for p24 antigen in diagnosing primary infection, they are more expensive and are more likely to yield false-positive results.

    *For participants in the Los Angeles County Primary HIV Infection Recruitment Network, see Appendix.

    Article and Author Information

    • †Deceased.

    • Note: The coauthors acknowledge the contribution of Janis V. Giorgi, PhD, who died on 30 May 2000. Dr. Giorgi, an internationally recognized cellular immunologist, will be remembered for her influence on her colleagues and for the profound impact of her work on the understanding of HIV immunopathogenesis.

    • Acknowledgments: The authors thank Dr. J. Elashoff for biostatistical support; C.-K. Chan, J. Gazola, S. Albanil, J. Vega, and N. Keating for technical assistance; Chiron Diagnostics for HIV RNA assays; and all patients who agreed to undergo screening for primary HIV infection in Los Angeles and San Diego.

    • Grant Support: In part by the Universitywide AIDS Research Program, University of California (PH97-SD-201, PH97-CS-202, General Clinical Research Center grant M01-RR00425); National Center for Research Resources, the Women's Guild (AI 43638, AI 27670, AI 38858, AI 36214 [Center for AIDS Research]); the National Institutes of Health (AI29164); the Research Center for AIDS and HIV Infection of the San Diego Veterans Affairs Medical Center; and the Women's Guild.

    • Requests for Single Reprints: Eric S. Daar, MD, Division of Infectious Diseases, Cedars-Sinai Medical Center, B217, 8700 Beverly Boulevard, Los Angeles, CA 90048; e-mail: Daar@CSHS.org.

    • Current Author Addresses: Drs. Daar, Ho, Bai, and Gaut and Ms. Pitt: Division of Infectious Diseases, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048.

    • Dr. Little: University of California, San Diego, 2760 Fifth Avenue, Suite 300, San Diego, CA 92103.

    • Ms. Santangelo: University of California, San Diego, 9500 Gilman Drive #8208, San Diego, CA 92093-8208.

    • Ms. Harawa: HIV Epidemiology Program, Los Angeles County Department of Health Services, 600 South Commonwealth Boulevard, Suite 1920, Los Angeles, CA 90005.

    • Dr. Kerndt: Los Angeles County Department of Health Services STD Program, 2615 South Grand Avenue, Room 500, Los Angeles, CA 90007.

    • Dr. Richman: Department of Pathology and Medicine-0679, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0679.

    • Dr. Mandel: Los Angeles Free Clinic, 8405 Beverly Boulevard, Los Angeles, CA 90048.

    • Dr. Nichols: Department of Pathology, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048.

    • Author Contributions: Conception and design: E.S. Daar, J. Pitt, P. Kerndt, J.V. Giorgi.

    • Analysis and interpretation of the data: E.S. Daar, S. Little, P. Ho, D.D. Richman.

    • Drafting of the article: E.S. Daar, D.D. Richman.

    • Critical revision of the article for important intellectual content: E.S. Daar, S. Little, J. Pitt, P. Ho, N. Harawa, P. Kerndt, J. Bai, P. Gaut, D.D. Richman, S. Mandel, S. Nichols.

    • Final approval of the article: E.S. Daar, S. Little, J. Pitt, P. Ho, N. Harawa, P. Kerndt, J. Bai, P. Gaut, D.D. Richman, S. Mandel, N. Nichols.

    • Provision of study materials or patients: E.S. Daar, S. Little, J. Pitt, N. Harawa, P. Kerndt, P. Gaut, D.D. Richman, S. Mandel.

    • Obtaining of funding: E.S. Daar, S. Little.

    • Administrative, technical, or logistic support: J. Pitt, P. Kerndt, J. Bai.

    • Collection and assembly of data: E.S. Daar, S. Little, J. Pitt, J. Santangelo, P. Ho.

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    1. Ann Intern Med January 2, 2001 vol. 134 no. 1 25-29
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