Balfour (1996) |
The United States |
Multicenter, open-label, randomized clinical trial |
Patients with AIDS, age >18 years, Karnofsky ≥ 60, with life expectancy ≥ 6 months, CD4 counts less than 200 mL, CMV viremia, who have never manifested invasive CMV disease (n = 27). |
Pregnant or lactating women, active CMV disease, previous treatment of CMV disease with foscarnet or ganci-clovir, treatment with acyclovir in recent weeks, and treatment with renal tubular excretion inhibitors or loop diuretics. |
Foscarnet in four different doses, administered IV for 10 days: 15 mg/kg every 8 h, 30 mg/kg every 8 h, 45 mg/kg every 12 h, 90 mg/kg every 12 h (n = 22). |
Non- treatment(n=5) |
CMV EOD, all-cause mortality
|
Reductions in the levels of CMV and HIV-1 viremia correlated quantitatively with systemic exposure to foscarnet, whereas control subjects experienced an increase in CMV and HIV-1 burdens. |
Salmon-Ceron (1999) |
France |
Multicenter, open-label, randomized clinical trial. |
Age > 18 years, with CD4 cell count ≤ 100 mL, two positive blood cultures for CMV in the three months prior to inclusion (the last within 14 days prior to inclusion), no active or past CMV organ disease (n = 42). |
Unexplained fever or other symptoms suggestive of CMV target organ disease or any of the following: a hemoglobin level less than 9 g/dL, serum creatinine > 150 mmoL/L, or serum calcium or phosphate ≥ 20% above or below normal. |
Foscarnet 100 mg/kg every 12 h IV for 14 days (n = 21). |
Non- treatment (n = 21) |
CMV EOD, all-cause mortality, adverse events, withdrawal of the therapy and withdrawal of the therapy due to adverse events
|
Sequential courses of intravenous foscarnet might not be a good strategy for preemptive therapy in this population. In patients with a positive blood marker, treatment able to induce and maintain negative CMV blood cultures could constitute an effective intervention. |
Spector (1998) |
The United States |
Randomized, double-blind, clinical trial. |
HIV-positive adults with CD4 ≤ 50 cells/mL on two occasions within 30 days prior to randomization or CD4 count ≤ 100 cells/mL in those with documented history of AIDS-defining opportunistic infections and baseline CMV-positive viral load (n = 281). |
Pastor present CMV disease, history of treatment for CMV, active gastrointestinal disease, absolute neutrophil count < 750 cells/mL, platelet count < 50,000 cells/mL, estimated creatinine clearance rate < 70 mL/min or a score < 60 on the Karnofsky scale |
Ganciclovir 1000 mg orally every 8 h, mean duration 269 days (n = 191). |
Placebo (n = 90) |
CMV EOD
|
In persons with advanced AIDS, phophylactic oral ganciclovir significantly reduces the risk of CMV disease. |
Wohl (2009) |
The United States |
Randomized, double-blind, clinical trial. |
Adults with HIV, with IgG (+) for CMV, no evidence of EOD, with CD4+ < 100 mL and plasma HIV CV > 400 copies/mL in the 30 days prior to admission. Subjects had to have been receiving ART continuously for three months or not receiving and not planning to start ART (n = 47). |
Not defined by the authors |
Induction with valganciclovir 900 mg/kg orally twice daily, followed by maintenance therapy with valganci-clovir 900 mg/kg orally every day, mean duration 54.7 weeks (n = 24). |
Placebo (n = 23) |
CMV EOD, all-cause mortality
|
Preemptive anti-CMV therapy in patients with persistently low CD4+ cell counts in the current treatment era may not be warranted given the low incidence of CMV EOD and high all-cause mortality observed in this study population. |