|
A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients Clinical research trials and A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients. A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients clinical trial. Human subjects frequently get the finest healthcare available for their A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients  A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients
A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients
For Condition: Toxoplasmosis, Cerebral,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome
Synopsis: To determine the manner in which pyrimethamine is metabolized and excreted in patients currently receiving zidovudine (AZT). An important goal of this measurement is to establish the optimal dose of pyrimethamine necessary to prevent the development of toxoplasmosis in AIDS patients or delay the subsequent return of toxoplasmic encephalitis. Encephalitis caused by Toxoplasma gondii has emerged as the most frequent cause of focal central nervous system infection in patients with AIDS. Untreated, the encephalitis is fatal. The best treatment for this disease has not been determined. Presently it is standard practice to administer a combination of pyrimethamine and sulfadiazine. Little is known about the pharmacokinetics of pyrimethamine in patients with AIDS receiving AZT. Furthermore, there are reports that patients already exposed to toxoplasmosis may not have uniform absorption of pyrimethamine.
Details: Encephalitis caused by Toxoplasma gondii has emerged as the most frequent cause of focal central nervous system infection in patients with AIDS. Untreated, the encephalitis is fatal. The best treatment for this disease has not been determined. Presently it is standard practice to administer a combination of pyrimethamine and sulfadiazine. Little is known about the pharmacokinetics of pyrimethamine in patients with AIDS receiving AZT. Furthermore, there are reports that patients already exposed to toxoplasmosis may not have uniform absorption of pyrimethamine. Patients receive the study treatment for a total of 22 days. Patients are given an initial dose of pyrimethamine followed by a lower dose given as a single oral daily dose for 21 days. Patients continue to receive AZT at the dose prescribed prior to enrollment in the study. Patients receive leucovorin calcium once a day. Neither the leucovorin calcium nor the AZT are provided through the study.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis. - Isoniazid not initiated during study period. - Methadone maintenance. Required: - Stable prescribed dose of zidovudine (AZT) of at least 500 mg/day. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Prior history of toxoplasmic encephalitis. - Unable to take oral medication reliably or have a malabsorption syndrome (i.e., 3 or more loose stools/day for at least 4 weeks associated with an unintentional weight loss of = or > 10 percent of body weight). - History of sensitivity to the study medications. Concurrent Medication: Excluded: - Maintenance therapy for opportunistic infections with macrolides or sulfonamides, immunomodulators, rifampin, amphotericin, dapsone, ganciclovir, antifolates, probenecid, benzodiazepines, nephrotoxins, and experimental cytotoxic chemotherapy. - Medications such as aspirin, benzodiazepines, cimetidine, indomethacin, morphine, and sulfonamides should be avoided. Concurrent Treatment: Excluded: - Lymphocyte replacement. Patients with the following are excluded: - Any medical or social condition that, in the opinion of the investigator, would adversely affect either participation or compliance in the study. - Diagnosis of AIDS and febrile and have evidence of another serious opportunistic infection or central nervous system impairment. Prior Medication: Excluded: - Maintenance therapy for opportunistic infections with macrolides or sulfonamides, immunomodulators, rifampin, amphotericin, dapsone, ganciclovir, antifolates, probenecid, benzodiazepines, nephrotoxins, and experimental cytotoxic chemotherapy within past 14 days. Prior Treatment: Excluded: - Lymphocyte replacement within past 14 days. Patients have the following symptoms and conditions: - Laboratory evidence of HIV infection. - Serological evidence of exposure to Toxoplasma gondii, but no clinical evidence of active toxoplasmic infection. - Able to understand and sign a written informed consent. - Either homosexual male or intravenous drug user. Required: - Stable prescribed dose of zidovudine (AZT) of at least 500 mg/day for 4 weeks. Intravenous drug abuse.
Total Enrollment: 26
Location and Contact Information:
Overall Study Official:
BLuft, Study Chair,
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304
United States
Additional Information:
Study ID Numbers: ACTG 102;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000973
Other Hiv Infections Studies:
1. The Effect of Anti-HIV Therapy on Fat Metabolism in HIV-Positive Patients
2. A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B)
3. The Effects of Anti-HIV Therapy on the Immune Systems of Children Infected With HIV
4. A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs
5. A Comparison of Zidovudine (AZT) Used Alone or in Combination with Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Palo Alto Clinical Trials
A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients
|
|
|
|
|
|
|
|
