The optimal time to initiate therapy is unknown among persons with asymptomatic disease and CD4+ T cell count of >200 cells/mm3. This table provides general guidance rather than absolute recommendations for an individual patient. All decisions regarding initiating therapy should be made on the basis of prognosis as determined by the CD4+ T cell count and level of plasma HIV RNA, the potential benefits and risks of therapy and the willingness of the patient to accept therapy.

Clinical Category	CD4+ Cell Count	Plasma HIV RNA	Recommendation
Symptomatic (AIDS or severe symptoms)	Any value	Any value	Treat
Asymptomatic,AIDS	CD4+ T cells<200/mm3	Any value	Treat
Asymptomatic	CD4+ T cells>200/mm3 but<350/mm3	Any value	Treatment should be offered, although controversial.*
Asymptomatic	CD4+ T cells>350/mm3	> 55,000 (by RT-PCRor bDNA)#	Some experienced cliniciansrecommend initiating therapy, recognizing that the 3-year risk for untreated patients to develop AIDS is > 30%; in the absence of increased levels of plasma HIV RNA, other clinicians recommend deferring therapy and monitoring the CD4+ T cell count and level of plasma HIV RNA more frequently; clinical outcomedata after initiating therapy are lacking.
Asymptomatic	CD4+ T cells>350/mm3	< 55,000 (by RT.PCRor bDNA)#	Most experienced clinicians recommend deferring therapy and monitoring the CD4+ T cell count, recognizing that the 3-year risk for untreated patients to experience AIDS is < 15%.

*

Clinical benefit has been demonstrated in controlled trials only for patients with CD4+ T cells <200/mm³, however, the majority of clinicians would offer therapy at a CD4+ T cell threshold <350/mm³. A recent evaluation of data from the Multicenter AIDS Cohort Study (MACS) of 231 persons with CD4+ T cell counts > 200 and < 350 cells/mm3 demonstrated that of 40 (17%) persons with plasma HIV RNA <10,000 copies/mL, none progressed to AIDS by 3 years (Source: Phair JP, Mellors JW, Detels R, Margolick JB, Muñoz A. Virologic and immunologic values allowing safe deferral of antiretroviral therapy. AIDS 2002; 16(18): 2455-9). Of 28 persons (29%) with plasma viremia of 10,000.20,000 copies/mL, 4% and 11% progressed to AIDS at 2 and 3 years respectively. Plasma HIV RNA was calculated as RT-PCR values from measured bDNA values.

#

Although a 2.2.5 fold difference existed between RT-PCR and the first bDNA assay (version 2.0), with the 3.0 version bDNA assay, values obtained by bDNA and RT-PCR are similar except at the lower end of the linear range (<1,500 copies/mL).

(For additional information, see .Considerations for Initiating Therapy for the Patient with Asymptomatic HIV-1 Infection, DHHS guidelines, April 7th, 2005.)

Adapted from DHHS guidelines, April 7th, 2005