Sha B, Benson C, Deutsch T, Pottage J, Urbanski P, Kessler H; International Conference on AIDS.
Int Conf AIDS. 1990 Jun 20-23; 6: 232 (abstract no. Th.B.441).
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, USA
OBJECTIVE: To evaluate the efficacy and safety of high dose IV ACV in combination with zidovudine (ZDV) as suppressive therapy for CMV retinitis in AIDS patients. METHODS: A single arm, open-label, phase 2 pilot study using ACV 10 mg/kg IV q 8 hours plus ZDV 200 mg p.o. q 4 hours as suppressive therapy for CMV retinitis. Patients selected met the following criteria: Ophthalmologically documented CMV retinitis with salvageable vision defined as visual acuity of 20/100 or better in at least one eye and successful completion of at least 14 days of induction ganciclovir (5 mg/kg IV q 12 hours) within 48 hours of enrollment; age greater than 13 years; Karnofsky score greater than 60% at entry; and ability to provide informed consent. Patients were to be treated for 12 weeks and followed weekly for drug toxicity and evidence of ophthalmologic progression. RESULTS: Since 7/89, 8 patients have been enrolled. Two patients are currently on study and stable at week 2 and 3, respectively. Of the remaining 6 patients, 2 were dropped from the study within the first week of therapy due to development of another life-threatening opportunistic infection. One patient progressed at 2.5 weeks concomitant with a diagnosis of disseminated MAI. One patient progressed at 4 weeks, but was only on drug approximately 50% of the time due to poor compliance. The other 2 patients progressed at week 7 and 8 of therapy. One patient developed reversible renal toxicity (creatinine 2.8) secondary to volume depletion from an intercurrent illness. Three patients required dose reduction of ZDV due to anemia. CONCLUSION: Our preliminary results demonstrate high dose IV ACV is well tolerated and can be safely administered with ZDV. This regimen may be effective in suppressing CMV retinitis in patients who have completed successful induction remission therapy with ganciclovir; further efficacy evaluation will require larger numbers of patients.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Acyclovir
- Cytomegalovirus Retinitis
- Disease Progression
- Ganciclovir
- Humans
- Visual Acuity
- Zidovudine
Other ID:
UI: 102182018
From Meeting Abstracts