A randomized prospective study to compare early versus delayed access to antiretroviral therapy over clinical and immunological sequel in HIV-positive adults

BACKGROUND: Antiretroviral therapy (ART) is the cornerstone for the treatment of human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS). Our study aimed to compare the impact of early versus delayed access to ART over clinical and immunological outcomes in HIV-positive adults. METHODS: The prospective, randomized, open-label study was conducted for nine months, and comprised HIV-positive adults who presented to the ART center. Patients who presented early in their course of disease with baseline cluster of differentiation (CD) 4 count ≥350/mm(3) were recruited in the early arm and in the late arm, if <350/mm(3). The primary objectives were to evaluate disease progression in terms of the Centers for Disease Control and Prevention (CDC) stages, functional status, and opportunistic infections. Statistical analysis was done by applying an unpaired t-test, analysis of variance (ANOVA), Chi-square test, and Kaplan–Meier analysis with a P value <0.05 as significant at a 95% confidence interval. RESULTS: A total of 134 HIV-positive patients meeting eligibility criteria were randomized. All patients including 60 in the early and 74 in the late arm received tenofovir + lamivudine + efavirenz (TLE). There was a significant difference in CDC stages and immunological status at baseline and post ART initiation (p-value < 0.001). TB-HIV co-infections were significantly (p-value = 0.006) more in late arm. CONCLUSION: The study suggests CD4 counts at ART initiation, as the most important factor in predicting post-treatment recovery in terms of clinical and immunological outcomes.