NEWS HIGHLIGHTS
Published Studies Related to Mepron (Atovaquone)
Prolonged Protection Provided by a Single Dose of Atovaquone-Proguanil for the Chemoprophylaxis of Plasmodium falciparum Malaria in a Human Challenge Model. [2011.11.03]
Background. We conducted a randomized, placebo-controlled, double-blind trial to establish the efficacy of atovaquone-proguanil to prevent malaria with the goal of simulating weekly dosing in a human Plasmodium falciparum challenge model.Methods.Postexposure prophylaxis 4 days after challenge was 100% effective.
Efficacy of atovaquone and azithromycin or imidocarb dipropionate in cats with acute cytauxzoonosis. [2011.01]
BACKGROUND: Imidocarb or a combination of atovaquone and azithromycin (A&A) has been suggested for treatment of cats with cytauxzoonosis, but neither has been prospectively evaluated for efficacy. HYPOTHESIS/OBJECTIVES: That survival to hospital discharge is improved by treatment with A&A as compared with imidocarb...
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.
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.
Antiretroviral Drug Interaction Study in Volunteers With HIV [Recruiting]
Background:
- People who are infected with the human immunodeficiency virus (HIV) are at risk of getting
certain diseases. Two of these diseases are a type of pneumonia known as PCP and a brain
infection called toxoplasmosis. Most people with HIV take antiretroviral (ARV) drugs to
treat HIV and lower the risk of infections. However, some ARV drugs may make other drugs
used to treat PCP and toxoplasmosis less effective. Researchers want to test specific ARV
drugs to see if they affect atovaquone, a drug used to treat PCP and toxoplasmosis.
Objectives:
- To see if ARV drugs atazanavir-ritonavir or efavirenz lower the blood levels of
atovaquone.
Eligibility:
- Individuals between 18 and 70 years of age who have HIV.
- Participants must be taking efavirenz or atazanavir-ritonavir, or not taking any ARV
drugs.
Design:
- Participants will be screened with a physical exam and medical history. They will also
have blood and urine tests.
- This study has a screening visit and five study visits. Two of the study visits will
last about 12 hours; the other three visits will last about 1 hour each.
- Participants will receive either a low dose or high dose of atovaquone to take for 14
days. They will record doses and any symptoms on a diary card at home.
- After 14 days, participants will have a 12-hour visit to provide blood samples. There
will be a wash-out period with no doses for up to 6 weeks.
- After the wash-out period, participants will switch dose levels to either the high or
low dose.
- After 14 days, participants will have a 12-hour visit to provide blood samples.
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.
Reports of Suspected Mepron (Atovaquone) Side Effects
Chest Pain (5),
Pericardial Effusion (4),
Death (4),
Myalgia (4),
Neck Pain (4),
Product Quality Issue (4),
Pain in Extremity (4),
Abdominal Pain (2),
Drug Ineffective (2),
Abdominal Pain Upper (2), more >>
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