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The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs Clinical research trials and The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs. The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs clinical trial. Human subjects often receive the most effective healthcare possible for their The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs  The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: To compare the durability of the viral load response following 48 weeks of treatment with 1592U89/lamivudine (3TC)/zidovudine (ZDV) versus 3TC/ZDV alone. To compare the early antiviral activity following 16 weeks treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone as demonstrated by the proportion of subjects with viral load < 400 copies/ml, plasma HIV-1 RNA profiles and CD4+ profiles. To assess the safety and tolerance following 16 and 48 weeks of treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone.
Details: This study compares the safety and efficacy of 1592U89 in combination with 3TC and ZDV versus control therapy with 3TC and ZDV alone. If a patient has two consecutive HIV-1 RNA measurements of >= 400 copies/ml (performed at least one week apart) he or she has the option to switch to open-label therapy with 1592U89/3TC/ZDV, to receive the remaining randomized treatment, or to discontinue study medication. If this criterion is not met, patients continue their randomly assigned therapy until the last patient has completed 48 weeks of therapy. Once patients enter the open-label phase, investigators may add or substitute non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, or protease inhibitors for 3TC and/or ZDV according to their standard practice once patients enter the open-label phase.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Local treatment for Kaposi's sarcoma. - Hematologic supportive therapy with GM-CSF, G-CSF, or erythropoietin. Patients must have: - HIV-1 infection as documented by a licensed HIV-1 antibody ELISA and confirmed by either Western blot detection of HIV-1 antibody or positive HIV-1 blood culture. - One screening CD4 lymphocyte cell count >= 100 cells/mm3 within 14 days prior to study drug administration. - No active or ongoing AIDS-defining opportunistic infection or disease. - Signed, informed consent from parent or legal guardian for patients under 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: - Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption or render the patient unable to take oral medication. - Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that, in the opinion of the investigator, would compromise the safety of the patient. Concurrent Medication: Excluded: - Foscarnet therapy. - Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents, or interferons. - Cytotoxic chemotherapeutic agents and antioxidants. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded: History of clinically relevant pancreatitis or hepatitis within the last 6 months. Prior Medication: Excluded: - Prior antiretroviral therapy. - Vaccination within the past 3 months given as part of an investigational HIV vaccine trial. - Chemotherapeutic agents within 30 days of study drug administration. - Immunomodulating agents such as systemic corticosteroids, interleukins or interferons, within 30 days of study drug administration. Prior Treatment: Excluded: Radiation therapy within 30 days of study period. Current alcohol or illicit drug use that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing schedule and protocol evaluations.
Total Enrollment: 210
Location and Contact Information:
Boston Med Ctr / Evans - 556
Boston, Massachusetts, 021182393
United States
Baylor College of Medicine / Dept of Medicine
Houston, Texas, 770303498
United States
St Vincent's Hosp and Med Ctr / AIDS Ctr
New York City, New York, 10011
United States
San Juan AIDS Program
Santurce, , 00907
Puerto Rico
Rush Med College / Rush Presbyterian - St Luke's Med Cen
Chicago, Illinois, 60612
United States
Harlem Hosp
New York City, New York, 10027
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Dr Nicholaos Bellos
Dallas, Texas, 75225
United States
Univ of Miami Dept of Medicine
Miami, Florida, 33136
United States
Toronto Gen Hosp
Toronto, Ontario,
Canada
Kraus Med Partners
Los Angeles, California, 90036
United States
Saint Michael's Med Ctr / Dept of Infectious Diseases
Newark, New Jersey, 07102
United States
Duke Univ Med Ctr / Dept of Medicine
Durham, North Carolina, 27710
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, 452670405
United States
Additional Information:
Study ID Numbers: 238D;
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002389
Other Hiv Infections Studies:
1. A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
2. Comparison of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS
3. Prenatal and Postnatal Studies
4. A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
5. The Safety and Effectiveness of Ribavirin in the Early Stages of HIV-Infection
Related Studies:
Other HIV Infections Clinical Trials
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Other Cincinnati Clinical Trials
The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
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