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Jonathan Berman

Publications and source records attributed to Jonathan Berman.

10 recordsLinked to original sources
PubMed2006

Visceral leishmaniasis in the New World & Africa.

Visceral leishmaniasis in the New World, primarily found in northeastern Brazil, is caused by Leishmania chagasi. Compared to India, unusual features of Brazilian disease are the large number of asymptomatic infections versus symptomatic infections, and the apparent change from a zoonotic disease to a partially anthroponotic one. Visceral disease in Africa is caused by L. donovani as in India, but disease differs from that in India in being zoonotic rather than anthroponotic, and in the large numbers of patients who acquire post-kala-azar dermal leishmaniasis.

Africa↗
PubMed2006

Randomized, double-blind, placebo-controlled study of Malarone for malaria prophylaxis in non-immune Colombian soldiers.

Malarone was compared with placebo in a double-blind, randomized, placebo-controlled trial of prophylaxis of malaria in predominately Plasmodium vivax areas of Colombia. The study population consisted of 180 completely non-immune Colombian soldiers, male, average age 19 years, and average weight 63 kg. Twenty-four subjects were considered unevaluable because of compliance issues, including one Malarone subject (with no detectable drug levels) who became infected with P. vivax. Of the 97 evaluable subjects who received Malarone (250 mg atovaquone plus 100 mg proguanil hydrochloride) daily from 1 day before entering the endemic area to 7 days after leaving the endemic area, none became parasitemic. Of the 46 evaluable placebo subjects, 11 became infected with P. vivax and 2 became infected with Plasmodium falciparum. The protective efficacy of Malarone for all malaria and for P. vivax malaria was 100% (LL 95% CI = 63%) and 100% (LL 95% CI = 58%), respectively, and was 96% if the one case with undetectable blood levels was included. Malarone has high protective efficacy for P. vivax in Colombia.

Adolescent↗
PubMed2005

Recent Developments in Leishmaniasis: Epidemiology, Diagnosis, and Treatment.

The outbreaks of cutaneous disease caused by Leishmania tropica in Afghan refugees, visceral disease in Sudanese refugees, and cutaneous disease caused by Leishmania major in American forces in Iraq are examples of the large number of cases of leishmaniasis that can result when naive human populations intrude into regions where transmission is endemic. Injections of pentavalent antimony for 20 to 30 days have been the standard treatment for all forms of leishmaniasis, but resistance is growing and antimonials have moderate toxicity. Two major advances in the treatment of visceral leishmaniasis have been made in the past few years. Liposomal amphotericin B cures virtually all patients, with little side effects. Miltefosine is the first oral agent that is effective. For cutaneous disease, alternatives to antimony have been effective in certain regions but have not yet been generally evaluated.

Journal Article↗
PubMed2005

Clinical status of agents being developed for leishmaniasis.

Leishmaniasis, which exists in both visceral and cutaneous forms, is currently treated with intramuscular antimony or intravenous amphotericin B. The primary unmet need is for oral therapy. Of the several drugs in clinical development, miltefosine is unique in being an oral agent with efficacy against both forms of the disease. Sitamaquine is an oral agent with substantial but not sufficient efficacy against visceral disease. Oral fluconazole has been shown to be more effective than placebo in one instance: for Leishmania major cutaneous disease from Saudi Arabia. Paromomycin is in widespread trial. Topical paromomycin formulations are being tested for cutaneous disease, and intramuscular paromomycin is in Phase III trial for Indian visceral disease. The most likely replacements for present therapy are oral miltefosine for many of the visceral and cutaneous syndromes, intramuscular paromomycin for visceral disease and topical paromomycin for some forms of cutaneous disease.

Aminoquinolines↗
PubMed2005

Miltefosine to treat leishmaniasis.

Leishmaniasis exists in both visceral and cutaneous forms, and miltefosine is the first oral agent with demonstrable efficacy against both types of this disease. At a dose of approximately 2.5 mg/kg/day for 28 days, miltefosine is > 90% curative for visceral disease in India and cutaneous disease in Colombia. Miltefosine is a lecithin analogue and its mechanism may be to inhibit phosphatidylcholine biosynthesis in the causative parasites. The clinical half-life of miltefosine is approximately 7 days. Whether or not miltefosine can be used for widespread out-patient treatment of individuals and whole populations depends on whether its efficacy and tolerability can be maintained in further treatment trials.

Administration, Oral↗
PubMed2003

Current treatment approaches to leishmaniasis.

PURPOSE OF REVIEW: The leishmaniases consist of cutaneous, mucosal, and visceral syndromes. The classic treatment is with pentavalent antimonials. The disadvantages of the antimonials are their requirement for intramuscular or intravenous injection each day for 20-28 days, their toxicity, and the recent development of resistance in regions such as India. Amphotericin B is a potent secondary agent, but is also compromised by its parenteral nature and toxicity. Clinical investigation of treatment agents from January 2000 to January 2003 is reviewed to determine if there are new agents that can be used. RECENT FINDINGS: A large number of pilot studies on visceral and cutaneous leishmaniasis have been performed. There can be more confidence in the visceral studies because visceral disease is incurable if untreated, and because large numbers of patients have been treated in highly endemic regions such as India. There is less confidence in pilot studies of the cutaneous disease, because most are uncontrolled, and there is a variable, and often high, cure rate without treatment. SUMMARY: Liposomal amphotericin B, which is injected infrequently and is easily tolerated, is virtually 100% effective for Indian visceral disease at a total dose of 15 mg/kg and is 90% effective at a dose of 5-10 mg/kg. The oral agent, miltefosine, is more than 95% effective for Indian visceral disease. Fluconazole treatment for 6 weeks speeds up the already-rapid cure rate of cutaneous disease due to Leishmania major.

Amphotericin B↗
PubMed2003

Oral miltefosine treatment in children with mild to moderate Indian visceral leishmaniasis.

BACKGROUND: Miltefosine is the first oral drug with demonstrable success in treating visceral leishmaniasis in adults. Because approximately one-half of the visceral leishmaniasis patients worldwide are children, we performed a Phase I/II dose ranging study in the pediatric population in India. METHODS: Thirty-nine (39) children (defined as < 12 years of age) with visceral leishmaniasis demonstrated by parasites in splenic aspirates, were treated with oral miltefosine daily for 28 days: 21 patients received 1.5 mg/kg/day (Group A); and 18 patients received 2.5 mg/kg/day (Group B). About one-half of these children had failed prior antileishmanial treatment. RESULTS: All patients were parasitologically negative and symptomatically improved by the end of therapy on Day 28 of therapy; the initial parasitologic cure rate was 100%. Two patients in each treatment group relapsed with fever, splenomegaly and parasite-positive splenic aspirates by the end of the 6-month follow-up. The per protocol final clinical cure rate was 19 of 21 = 90% in Group A and 15 of 17 = 88% in Group B. Miltefosine was well-tolerated. As per the adult experience, gastrointestinal adverse events were seen: 33 and 39% of children experienced vomiting and 5 and 17% experienced diarrhea in Groups A and B, respectively, but all episodes were mild to moderate in severity and commonly lasted <1 day without symptomatic treatment. CONCLUSION: Oral miltefosine was safe and approximately 90% effective in this initial clinical trial of childhood visceral leishmaniasis.

Administration, Oral↗
PubMed2002

Oral miltefosine for Indian visceral leishmaniasis.

BACKGROUND: There are 500,000 cases per year of visceral leishmaniasis, which occurs primarily in the Indian subcontinent. Almost all untreated patients die, and all the effective agents have been parenteral. Miltefosine is an oral agent that has been shown in small numbers of patients to have a favorable therapeutic index for Indian visceral leishmaniasis. We performed a clinical trial in India comparing miltefosine with the most effective standard treatment, amphotericin B. METHODS: The study was a randomized, open-label comparison, in which 299 patients 12 years of age or older received orally administered miltefosine (50 or 100 mg [approximately 2.5 mg per kilogram of body weight] daily for 28 days) and 99 patients received intravenously administered amphotericin B (1 mg per kilogram every other day for a total of 15 injections). RESULTS: The groups were well matched in terms of age, weight, proportion with previous failure of treatment for leishmaniasis, parasitologic grade of splenic aspirate, and splenomegaly. At the end of treatment, splenic aspirates were obtained from 293 patients in the miltefosine group and 98 patients in the amphotericin B group. No parasites were identified, for an initial cure rate of 100 percent. By six months after the completion of treatment, 282 of the 299 patients in the miltefosine group (94 percent [95 percent confidence interval, 91 to 97]) and 96 of the 99 patients in the amphotericin B group (97 percent) had not had a relapse; these patients were classified as cured. Vomiting and diarrhea, generally lasting one to two days, occurred in 38 percent and 20 percent of the patients in the miltefosine group, respectively. CONCLUSIONS: Oral miltefosine is an effective and safe treatment for Indian visceral leishmaniasis. Miltefosine may be particularly advantageous because it can be administered orally. It may also be helpful in regions where parasites are resistant to current agents.

Administration, Oral↗