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A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients Clinical research trials and A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients healthcare trials happen in hundreds of localities 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients. A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients clinical trial. Subjects frequently obtain the most expert healthcare possible for their A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients  A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients
A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain alcohol) when they are given together.
Details: Patients are randomized to one of the following three regimens: Regimen 1: 1592U89 alone. Regimen 2: pure grain alcohol diluted in orange juice. Regimen 3: 1592U89 plus pure grain alcohol diluted in orange juice. Treatment is administered weekly for 3 weeks.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Local treatment for Kaposi's sarcoma. - Prophylactic treatment for opportunistic infections. Patients must have: - HIV-1 infection. - CD4+ lymphocyte count >= 200 cells/microliter within 14 days prior to study drug administration. - No active diagnosis of AIDS (other than visceral Kaposi's sarcoma) according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition. Prior Medication: Allowed: Local treatment for Kaposi's sarcoma. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Malabsorption syndrome or other GI dysfunction which may interfere with drug absorption. Concurrent Medication: Excluded: - Medications that cannot be withheld for 48 hours (24 hours for antiretrovirals) prior to study drug administration and until 12 hours after study drug administration on each dosing day. - Immunomodulators, such as systemic corticosteroids, interleukins and interferons. - Cytotoxic chemotherapeutic agents. - Acute treatment for opportunistic infections. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded: - Documented history of alcoholism. - History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration. - History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs. - Participation in another research study within the past month. Prior Medication: Excluded: - Cytotoxic chemotherapeutic agents within six weeks prior to study drug administration. - Immunomodulating agents within six weeks prior to study drug administration. - Treatment with the following within 2 weeks prior to study drug administration: - acyclovir, carbamazepine, chloramphenicol, ganciclovir, phenytoin, rifampin, sodium valproate, or valacyclovir. Prior Treatment: Excluded: Radiation therapy within 6 weeks prior to study drug administration. 1. Regular weekly alcohol intake of more than 21 units (a unit is equal to 1/2 pint beer or 1 glass of wine or 1 oz of liquor). - Recent change in normal pattern of alcohol usage (e.g., prolonged use followed by > one month abstinence). - Total abstinence from alcohol use. - Positive breath alcohol test upon arrival at the study center prior to any dosing day.
Total Enrollment:
Location and Contact Information:
PPD Development, Inc
Wilmington, North Carolina, 28412
United States
Additional Information:
Study ID Numbers: 238F; CNAA 1010
Study Start Date:
Record last reviewed: August 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002198
Other Hiv Infections Studies:
1. A Study of ALRT1057 in Patients with AIDS-Related Kaposi's Sarcoma
2. A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients
3. A Study of CI-1012 in HIV-Infected Patients
4. A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-phosphonylmethoxypropyl)cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
5. Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Wilmington Clinical Trials
A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients
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