The use of highly active antiretroviral therapy (HAART) in patients with advanced HIV infection: impact on medical, palliative care, and quality of life outcomes.

The effect of highly active antiretroviral therapy (HAART) in the treatment of HIV infection is usually measured by survival, CD4 lymphocyte counts, HIV-1 RNA viral load testing, and the occurrence of opportunistic infections. This pilot study sought to measure the impact of HAART treatments on a wide range of clinical outcomes and psychological variables in a sample of patients with advanced HIV infection. Seventy patients with advanced AIDS who were protease inhibitor naïve were started on HAART regimens. Patients were admitted to an AIDS inpatient unit of a long-term care facility that provides treatment and palliative care. All patients were diagnosed with AIDS, had CD4 cell counts below 300/cc(3), and had a projected survival of greater than one month. Patients were started on triple-drug HAART regimens with daily medical supervision and observation. In addition to standard clinical and laboratory markers, a series of observer-rated and self-report instruments were used to measure various physical and psychological factors (e.g., pain and symptom distress, psychological well-being, depression). Data were collected at baseline and after 1 and 3 months of HAART therapy. As expected, the CD4 count increased and viral load levels decreased significantly over the 3-month study period. In addition, patients improved significantly in body weight, and serum albumin and ferritin levels. The only psychosocial measure that improved significantly with treatment was depression. Ratings of pain intensity, physical and psychological symptom distress, and overall quality of life did not change. Of the 70 patients studied, 84.3% were still alive after the 3-month study period. Of these, 6 (8.6%) were discharged to community. However, 17 surviving patients (24.3%) had HAART regimens discontinued due to drug intolerance and 11 patients (15.7%) expired during the study period. While these data are preliminary, HAART regimens appear to have positive effects on CD4 count, HIV viral load, and several other measures of physical well-being in patients with advanced AIDS. Despite these improvements, the benefits of treatment on pain and symptom distress, and psychological well-being were less clear. In addition, treatment failure (mortality and intolerance) were not uncommon in this sample (40%). Further research is clearly necessary to better understand the benefits of HAART therapy in patients with advanced HIV infection.