Background & Aims: There is no clear end point for the response to treatment of gastrointestinal human cytomegalovirus (HCMV) disease. HCMV-DNA quantitation on gastrointestinal biopsy specimens has proven its value for the diagnosis of gastrointestinal HCMV disease in patients with acquired immunodeficiency syndrome (AIDS). The aim was to study HCMV-DNA levels on gastrointestinal biopsy specimens during the treatment of gastrointestinal HCMV disease. Methods: HCMV-DNA quantitation was performed using two different polymerase chain reaction assays on 90 biopsy specimens obtained before anti-HCMV therapy, during the induction phase, or during maintenance therapy for gastrointestinal HCMV disease in 21 patients with AIDS. Results: HCMV-DNA was detected on all the biopsy specimens ranging from 9 to greater than or equal to 80,000 Eq/0.1 mu g DNA. Pretherapeutic mean level was 69,000 +/- 27,000 Eq/0.1 mu g DNA. Induction therapy was followed by a mean decrease of 1.7 +/- 1.3 log(10) Eq/0.1 mu g DNA. HCMV-DNA levels decreased during induction therapy to <1000 Eq/0.1 mu g DNA in 60% of patients but remained >80,000 Eq/0.1 mu g DNA in 20% of patients. Relapse occurred in all the patients in a mean time of 100 days. HCMV-DNA level at the end of the induction phase seems to influence the time to relapse. Conclusions: Quantitation of HCMV-DNA on gastrointestinal biopsy specimens seems to be useful for monitoring gastrointestinal HCMV disease in patients with AIDS.