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Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs Clinical research trials and Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs. Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs clinical trial. Test subjects typically receive the most expert healthcare available for their Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): GlaxoSmithKline ,
Synopsis: The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).
Details: Patients receive TZV plus EFV in the 48-week Induction Phase. Eligible patients, defined as those with plasma HIV-1 RNA under 50 copies/ml, participate in the 48-week Maintenance Phase. Patients are randomized equally to receive either TZV plus EFV or TZV alone. An immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are at least 13 years old. - Are HIV-positive. - Have a viral load of at least 5,000 copies/ml. - Agree to use adequate and reliable methods of birth control. Note: Hormonal birth control is not considered adequate. - Provide written consent of a parent or guardian, if under 18 years of age. Exclusion Criteria Patients will not be eligible for this study if they: - Have taken nonnucleoside reverse transcriptase inhibitors. - Have taken other anti-HIV drugs for 2 weeks or more. - Have an opportunistic (AIDS-related) infection. - Are pregnant or breast-feeding. - Have had hepatitis within the past 6 months. - Are allergic to the study drugs or their ingredients. - Have a mental, physical, or substance abuse disorder. - Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease. - Have a gastrointestinal disorder that affects drug absorption or makes it difficult to take medication by mouth. - Have received within 4 weeks before study entry, or may require during the study period, radiation therapy, chemotherapy, or drugs that affect the immune system (such as steroid drugs, interleukins, vaccines, or interferons). - Have received an HIV vaccine within 3 months before study entry, or are scheduled to receive one during the study period. - Require foscarnet or other drugs that are shown to be effective against HIV. - Are taking astemizole, cisapride, midazolam, triazolam, or ergot derivatives. - Are taking experimental drugs. - Are unlikely to complete the study or take the drugs.
Total Enrollment: 400
Location and Contact Information:
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
United States
CRC of Mississippi
Jackson, Mississippi, 39202
United States
Pacific Horizons Med Group
San Francisco, California, 94115
United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
United States
Univ of Tennessee Med Ctr at Knoxville
Knoxville, Tennessee, 37920
United States
AIDS Outreach Center
Ft. Worth, Texas, 76104
United States
Dr Paul Benson
Berkley, Michigan, 48072
United States
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Summa Health System
Akron, Ohio, 44304
United States
HIV Outpatient Clinics / LA State Univ Med Ctr
New Orleans, Louisiana, 70112
United States
North Broward Hosp District / HIV Clinical Research
Ft. Lauderdale, Florida, 33311
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
United States
Cook County Gen Hosp / Division of Infect Diseases
Chicago, Illinois, 60612
United States
Northstar Med Clinic
Chicago, Illinois, 60657
United States
Wellness Ctr / Las Vegas
Las Vegas, Nevada, 89102
United States
Regions Hosp / HIV/AIDS Program
St. Paul, Minnesota, 55101
United States
Phoenix Body Positive
Phoenix, Arizona, 85006
United States
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, 80304
United States
ID Consultants
Charlotte, North Carolina, 28203
United States
NJCRI
Newark, New Jersey, 07103
United States
University of Louisville / ID Division
Louisville, Kentucky, 40202
United States
Therapeutic Concepts
Houston, Texas, 77004
United States
Hennepin County Med Ctr
Minneapolis, Minnesota, 55415
United States
Tarrant County Infectious Diseases Associates
Ft. Worth, Texas, 76104
United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22003
United States
Texas Tech Health Sciences Ctr
El Paso, Texas, 79905
United States
Health for Life Clinic
Little Rock, Arkansas, 72205
United States
Univ of Oklahoma Infectious Disease Institute
Oklahoma City, Oklahoma, 73117
United States
Infectious Disease Consultants
Fairfax, Virginia, 22030
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York City, New York, 10021
United States
Diversified Med Practices, PA
Houston, Texas, 77027
United States
Infectious Disease Consultants
Altamonte Springs, Florida, 32701
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
United States
Metroplex Infectious Disease
Ft. Worth, Texas, 76104
United States
Infectious Diseases Associates of Houston
Houston, Texas, 77030
United States
East Carolina Univ School of Medicine
Greenville, North Carolina, 27858
United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
United States
Swedish Med Ctr
Seattle, Washington, 98122
United States
SBMA Research
Miami, Florida, 33140
United States
Additional Information:
Study ID Numbers: 308B; ESS40013
Study Start Date: February 2001
Record last reviewed: March 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00011895
Other Hiv Infections Studies:
1. Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320
2. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived HIV-1 Recombinant Envelope Glycoprotein (gp160)
3. A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes
4. A Phase I/II Dose Escalation Study of Intradermal gp160 to Evaluate Safety, Delayed Type Hypersensitivity (Skin Test) Responses and Immunogenicity in Asymptomatic HIV Seropositive Patients With More Than 400 CD4+ Cells
5. Growth Hormone Treatment of Children with HIV-Associated Growth Failure
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Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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