NEWS HIGHLIGHTS
Published Studies Related to Mepron (Atovaquone)
Malaria treatment with atovaquone-proguanil in malaria-immune adults: implications for malaria intervention trials and for pre-exposure prophylaxis of malaria. [2008.04]
Eighty adults in areas of Kenya where malaria is holoendemic received presumptive treatment with atovaquone-proguanil and were followed closely. The time to the first Plasmodium falciparum parasitemia was 32 days.This prolonged prophylaxis period has implications for study design when used in malaria intervention trials and cautiously suggests clinical investigation of potential preexposure prophylaxis of malaria.
Atovaquone plus cholestyramine in patients coinfected with Babesia microti and Borrelia burgdorferi refractory to other treatment. [2006.01]
Ten percent of US patients with Lyme disease are coinfected with Babesia microti. A double-blind, placebo-controlled, crossover trial enrolled 25 patients with confirmed Borrelia burgdorferi/B microti coinfection, abnormal visual contrast sensitivity (VCS), and persistent symptoms despite prior treatment with atovaquone and azithromycin...
Atovaquone-proguanil for treating uncomplicated malaria. [2005.10.19]
CONCLUSIONS: Data are limited but appear to suggest that atovaquone-proguanil is more effective than chloroquine, amodiaquine, and mefloquine. There are insufficient data for comparisons against sulfadoxine-pyrimethamine, halofantrine, artesunate plus mefloquine, quinine plus tetracycline, and dihydroartemisinin-piperaquine-trimethoprim-primaquine in treating malaria. There are not enough data to assess safety, but a number of adverse events were identified with all drugs. Large trials comparing atovaquone-proguanil with other new combination therapies are needed.
A randomized comparison of artesunate-atovaquone-proguanil versus quinine in treatment for uncomplicated falciparum malaria during pregnancy. [2005.09.01]
BACKGROUND: There is no safe, practical, and effective treatment for pregnant women infected with multidrug-resistant Plasmodium falciparum... CONCLUSION: AAP is a well-tolerated, effective, practical, but expensive treatment for multidrug-resistant falciparum malaria during the second or third trimesters of pregnancy. Despite the small number of subjects, our results add to the growing body of evidence that AAP is safe for the mother and the fetus.
Short report: no evidence of cardiotoxicity of atovaquone-proguanil alone or in combination with artesunate. [2005.08]
Combinations are set to become the mainstay in treatment and prophylaxis of malaria due to Plasmodium falciparum.We conclude that atovaquone-proguanil shows no evidence of cardiotoxicity either alone or when combined with artesunate.
Clinical Trials Related to Mepron (Atovaquone)
Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children [Completed]
To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate
suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94
amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally
exposed (per 8/9/95 amendment) infants and children who are at risk of developing
Pneumocystis carinii pneumonia (PCP).
Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly
absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has
been prepared as a microparticulate suspension. Since studies in adults have demonstrated
substantial safety of this drug, evaluation in children is being pursued.
Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis [Completed]
To evaluate the efficacy, safety, and tolerance of atovaquone with either pyrimethamine or
sulfadiazine in AIDS patients with toxoplasmic encephalitis.
AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of
sulfadiazine and pyrimethamine experience a high frequency of severe toxicity. Atovaquone, an
antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in
preclinical testing has been well tolerated, is now available as a suspension, which is more
readily absorbed than the tablet form of the drug. The efficacy and safety of atovaquone in
combination with sulfadiazine or pyrimethamine will be studied.
A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX [Completed]
To assess whether high dose or low dose atovaquone suspension is more effective than
aerosolized pentamidine as prophylaxis against Pneumocystis carinii pneumonia (PCP) in
high-risk HIV-infected patients. To compare the safety of chronic administration of the three
regimens in patients with advanced HIV disease. To determine the relationship between steady
state atovaquone plasma concentrations and prophylactic efficacy against PCP.
A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia [Completed]
To facilitate provision of atovaquone (566C80) to patients who have mild to moderate
Pneumocystis carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim /
sulfamethoxazole (TMP / SMX ); to monitor serious adverse events attributable to 566C80.
An Open-Label, Uncontrolled Clinical Trial of Oral 566C80 for the Treatment of Patients With Severe PCP Who Are Intolerant and/or Unresponsive to Therapy With Trimethoprim/Sulfamethoxazole and Parenteral Pentamidine [Completed]
To facilitate provision of atovaquone (566C80) to patients who have severe Pneumocystis
carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim /
sulfamethoxazole ( TMX / SMX ); to monitor serious adverse events attributable to 566C80.
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