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.