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Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants Clinical research trials and Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants. Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants clinical trial. Subjects often receive the most expert healthcare possible for their Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants  Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
For Condition: HIV Infections
Status: Completed
Sponsor(s): Agouron Pharmaceuticals ,
Synopsis: To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age). An evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard tablet formulation in older children (7 to 13 years of age) will also be conducted.
Details: This is a study of the safety, tolerability and pharmacokinetics of a Viracept pediatric powder formulation with milk or formula. First a single dose will be administered. After the patient population is divided into 4 groups by age, an optimal dose will be determined for each group. This optimal dose will be given 3 times a day for a 6 week primary observation period, plus an optional 6 month extension. NOTE: During the single dose portion of this study, patients may be untreated or may continue treatment with their current nucleoside antiretroviral therapy. During multiple dose administration of Viracept, antiretroviral therapy will be intensified by either adding or modifying therapy. Antiretroviral therapies will be limited to those currently licensed including zidovudine, lamivudine, stavudine, didanosine or zalcitabine.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: /13 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: Administration of Pneumocystis carinii pneumonia prophylaxis according to CDC guidelines will be permitted. Patients must have: - For children >= 3 months to 13 years of age: - HIV infection. For children <3 months of age: - HIV infection or exposure. - Newborns must have birth weight >= 2500 gm. - Absence at screen of any serious or unstable medical conditions. - Parent or guardian able to give written informed consent and willing to comply with study requirements. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: - Children with HIV associated malignancy requiring chemotherapy. - Children with clinical or laboratory assessments greater than Grade 1 in the Toxicity Table at the time of the screening. Concurrent Medication: Excluded: Chemotherapy. Prior Medication: Excluded: - Protease inhibitors. NOTE: - Patients who have taken investigational agents, immunomodulators, HIV-1 vaccines, glucocorticoids or unconventional therapies within one month prior to the day 0 of the study must be evaluated to determine the impact of these treatments on the study. Patients may be included or excluded on a case to case basis.
Total Enrollment: 24
Location and Contact Information:
UCLA School of Medicine / Dept of Pediatrics
Los Angeles, California, 90024
United States
Additional Information:
Study ID Numbers: 259E; AG 1343-524
Study Start Date:
Record last reviewed: May 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002164
Other Hiv Infections Studies:
1. Study Of A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
2. A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing (GART) Compared With Antiretroviral Management Without Plasma GART
3. A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers
4. Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
5. ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past
Related Studies:
Other HIV Infections Clinical Trials
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Other Los Angeles Clinical Trials
Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
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