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An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects Clinical research trials and An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects. An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects clinical trial. Participants typically obtain the most effective healthcare available for their An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects  An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
For Condition: HIV Infections
Status: Completed
Sponsor(s): Lederle Laboratories ,
Synopsis: To characterize the pharmacokinetics of orally administered 3'-deoxy-3'-fluorothymidine (FLT), in a liquid formulation, after single doses in asymptomatic HIV-infected patients and to assess the safety and tolerance of the single oral doses of FLT.
Details:
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Oral candida infection documented by morphology or by response to antifungal therapy within 2 months prior to study entry. - Temperature > 37.8 degrees Centigrade. - Malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ. - Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial. Concurrent Medication: Excluded: Patients with the following are excluded: - Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial. - Unwilling to sign informed consent. - Intolerant to zidovudine (AZT). - Oral hairy leukoplakia at any time prior to study entry. Prior Medication: Excluded within 7 days of study entry: - Antiretroviral drugs. - Immunomodulators. - Excluded within 30 days of study entry: - Any investigational drugs. Patients have the following: - HIV seropositivity by licensed ELISA test, confirmed by Western Blot analysis. - No symptoms as defined by: a. Normal neurological exam. b. Absence of the following: - Unintentional weight loss of greater than 10 pounds or more than 10 percent of usual body weight within 2 months prior to study entry. - Unexplained temperature > 37.8 C on more than 5 consecutive days or on more than 10 days in any 30 day period in the one month prior to expected study entry. - Unexplained diarrhea defined by = or > 3 liquid stools per day persisting > 7 days within 2 months prior to expected study entry.
Total Enrollment:
Location and Contact Information:
Johns Hopkins Hosp
Baltimore, Maryland, 21205
United States
Additional Information:
Study ID Numbers: 054A; 81-1
Study Start Date:
Record last reviewed: June 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002271
Other Hiv Infections Studies:
1. A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria
2. A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
3. A Study of ABT-378/Ritonavir in HIV-Infected Patients
4. The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis carinii Pneumonia in Patients With AIDS
5. Hormone Replacement Therapy and Anti-HIV Drugs in HIV-Infected, Postmenopausal Women
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An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
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