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Home > "A" Clinical Trials Conditions > A Study of DPC 817 in HIV-Infected Males  A Study of DPC 817 in HIV-Infected Males
A Study of DPC 817 in HIV-Infected Males
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): Pharmasset ,
Synopsis: The purpose of this study is to evaluate DPC 817. The safety, dosages, and how the body responds to the drug will be studied.
Details: The study will consist of two parts. Patients in Part A will receive a single dose of DPC 817 on two separate occasions and a placebo (a solution or tablet without the drug) on one occasion. Patients in Part B will receive two separate doses of DPC 817. Patients will be admitted to the clinical study unit the day before dosing (Day -1) and remain there for at least 48 hours after taking the study drug. Patients will return to the clinical study unit on Day 8 and Day 28 following the dose in the last treatment period. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, and routine clinical laboratory tests.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV positive - Are male and are between 18 years of age (or the legal age of consent, whichever is older) and 55 years of age - Are female and are between 18 years of age (or the legal age of consent, whichever is older) and 55 years of age and are not able to have children (females may participate in Part B only) - Have no clinically significant findings on physical examination or clinical laboratory evaluations - Have a CD4-lymphocyte count of 50 or more cells/mm3 - Are able and willing to comply with the requirements of this study Exclusion Criteria Patients will not be eligible for this study if they: - Have an opportunistic infection characteristic of AIDS - Are receiving any approved or experimental HIV drugs. Any previous anti-HIV treatment must be stopped at least 4 weeks before the first dose of study medication - Are pregnant or breast-feeding - Are enrolled in other experimental drug studies or have recieved other experimental drugs within 30 days before the first dose of study drug - Have any disease that causes a problem with absorption of drugs - Have active hepatitis - Have a history of pancreatitis or peripheral neuropathy - Have received radiation therapy or chemotherapy within 30 days before the first dose of study drug - Have received treatment with drugs that affect the immune system within 30 days before the first dose of study drug or have received an HIV immunotherapeutic vaccine - Have taken prescription or over-the-counter products within 14 days of the first dose of study drug unless approved by the doctor - Are unable to comply with the dosing schedule and study procedures
Total Enrollment: 30
Location and Contact Information:
3ClincalResearch Center *Recruiting*
Berlin, ,
Germany
Recruiting Amanda Beard 678-395-0050
University of North Carolina Hospitals *Recruiting*
Chapel Hill, North Carolina, 27514
United States
Recruiting John Rublein 919-966-9545
Additional Information:
Study ID Numbers: DPC 817-201;
Study Start Date:
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040274
Other Hiv Infections Studies:
1. Safety of and Immune Response to an HIV Vaccine (VRC-HIVDNA009-00-VP) Administered With Interleukin-2/Immunoglobulin (IL-2/Ig) DNA Adjuvant in Uninfected Adults
2. A Study of Decreased Mental Function Associated with HIV
3. Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients
4. A Study of Capravirine Plus VIRACEPT Plus Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Patients Who Failed Previous Anti-HIV Treatments
5. A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
A Study of DPC 817 in HIV-Infected Males
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