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Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir) Clinical research trials and Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir) medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir). Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir) Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir) clinical trial. Participants frequently obtain the most expert healthcare available for their Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir) condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)  Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.
Details: Patients are randomized to receive either the triple combination tablet (Trizivir) or to receive Combivir plus abacavir as a separate tablet. Patients take their study medications for 24 weeks.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are at least 18 years old. - Are HIV-positive. - Are currently receiving one of the following anti-HIV drug combinations: Combivir plus abacavir, Combivir plus abacavir plus a protease inhibitor, or Combivir plus abacavir plus a non-nucleoside reverse transcriptase inhibitor (NNRTI). Patients must have been taking this drug combination for at least the past 16 weeks. This also must be the first anti-HIV drug combination the patient has received. - Have a viral load (level of HIV in the blood) less than or equal to 400 copies/ml. - Have CD4+ cell count greater than 200 cells/mm3. - Agree to use effective methods of birth control. Exclusion Criteria Patients will not be eligible for this study if they: - Have been diagnosed with AIDS. - Have a gastrointestinal disorder that makes it difficult for patients to absorb food or to take medications by mouth. - Have hepatitis. - Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease. - Are allergic to any of the study drugs. - Abuse alcohol or drugs. - Will not be available for the entire 24-week study period. - Are pregnant or breast-feeding. - Have taken or will need to take certain medications, including radiation therapy, chemotherapy, drugs that affect the immune system (such as interleukin), an HIV vaccine, foscarnet, and hydroxyurea. - Are enrolled in another experimental drug study.
Total Enrollment: 230
Location and Contact Information:
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
United States
New England Med Ctr
Boston, Massachusetts, 02111
United States
Nicholas Bellos
Dallas, Texas, 75246
United States
Saint Vincent's Hosp and Med Ctr
New York City, New York, 10011
United States
Tower Infectious Disease Med Ctr
Los Angeles, California, 90048
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Nashville Health Management Foundation / Vanderbilt Univ
Nashville, Tennessee, 37203
United States
AIDS Healthcare Foundation
Los Angeles, California, 900276069
United States
Therapeutic Concepts
Houston, Texas, 77004
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Univ of Tennessee
Memphis, Tennessee, 38163
United States
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 191021192
United States
St Lukes Medical Group
San Diego, California, 92101
United States
Robert Scott MD
Oakland, California, 94609
United States
Lehigh Valley Hosp
Allentown, Pennsylvania, 18105
United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213
United States
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
United States
Burnside Clinic
Columbia, South Carolina, 29206
United States
St Luke Roosevelt Hosp
New York City, New York, 10011
United States
Research Med Ctr
Kansas City, Missouri, 64111
United States
Univ of Texas Med Branch
Galveston, Texas, 77555
United States
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142
United States
Additional Information:
Study ID Numbers: 308A; ESS40005
Study Start Date:
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004981
Other Hiv Infections Studies:
1. A Study of Nevirapine Used Alone or in Combination with AZT in HIV-1-Infected Children
2. A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B)
3. A Study of L-735,524 in HIV-Positive Children and Adolescents
4. A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
5. A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines
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Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
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