Abstract | BACKGROUND: METHODS: The primary end point was photographically determined progression of cytomegalovirus retinitis within four weeks after the initiation of treatment. Secondary end points included the achievement of a prospectively defined satisfactory response to induction therapy and the time to progression of cytomegalovirus retinitis. After four weeks, all patients received valganciclovir as maintenance therapy. RESULTS: Eighty patients were randomly assigned to each treatment group. Of the patients who could be evaluated, 7 of 70 assigned to intravenous ganciclovir (10.0 percent) and 7 of 71 assigned to oral valganciclovir (9.9 percent) had progression of cytomegalovirus retinitis during the first four weeks (difference in proportions, 0.1 percentage point; 95 percent confidence interval, -9.7 to 10.0). Forty-seven of 61 patients (77.0 percent) assigned to intravenous ganciclovir and 46 of 64 (71.9 percent) assigned to valganciclovir had a satisfactory response to induction therapy (difference in proportions, 5.2 percentage points; 95 percent confidence interval, -20.4 to 10.1). The median times to progression of retinitis were 125 days in the group assigned to intravenous ganciclovir and 160 days in the group assigned to oral valganciclovir. The mean values for the area under the curve for the ganciclovir dosage interval were similar at both induction doses and maintenance doses. The frequency and severity of adverse events were similar in the two treatment groups. CONCLUSIONS:
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Authors | Daniel F Martin, Juan Sierra-Madero, Sharon Walmsley, Richard A Wolitz, Katherine Macey, Panos Georgiou, Charles A Robinson, Mary Jean Stempien, Valganciclovir Study Group |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 346
Issue 15
Pg. 1119-26
(Apr 11 2002)
ISSN: 1533-4406 [Electronic] United States |
PMID | 11948271
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiviral Agents
- Prodrugs
- Valganciclovir
- Ganciclovir
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Topics |
- AIDS-Related Opportunistic Infections
(drug therapy, pathology)
- Acquired Immunodeficiency Syndrome
(complications)
- Administration, Oral
- Adult
- Antiviral Agents
(blood, pharmacokinetics, therapeutic use)
- Cytomegalovirus
(isolation & purification)
- Cytomegalovirus Retinitis
(drug therapy, pathology)
- Disease Progression
- Female
- Ganciclovir
(analogs & derivatives, blood, pharmacokinetics, therapeutic use)
- HIV
(isolation & purification)
- Humans
- Injections, Intravenous
- Male
- Prodrugs
(pharmacokinetics, therapeutic use)
- Valganciclovir
- Viral Load
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