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A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART) Clinical research trials and A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART) healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART). A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART) Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART) clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART) condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)  A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)
A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to compare the effects of 3 HAART (anti-HIV) drug regimens on HIV in the blood. This study will also examine which HAART treatment is best as a first treatment for HIV infection. HAART has been shown to slow the progression of disease in HIV-positive patients. HAART is often given as a starting treatment for HIV infection, but it is not clear which drug regimen is best.
Details: Treatment with HAART regimens containing protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs) has been shown to slow disease progression. However, the long-term consequences of initial therapy with a PI, an NNRTI, or both a PI and an NNRTI are not yet known, nor is the impact on future AR treatment regimens. Patients who experience virologic failure on a particular HAART regimen typically have not been studied for subsequent response to other HAART regimens. It is possible that a regimen which is initially the most potent may not be optimal if it limits the effectiveness of subsequent AR therapies. [AS PER AMENDMENT 1/31/02: Over the past 2 years, treatment recommendations have become more conservative due to concerns about the loss of future drug options due to HIV resistance, poor adherence due to regimen complexity, and long-term toxicities associated with treatment. Thus, recently revised guidelines on antiretroviral therapy from the Department of Health and Human Services (DHHS) do not list triple-class therapy as an option. In addition, recent data indicates that, among persons on HAART, CD4 cell count is a better long-term predictor of AIDS and mortality than is HIV RNA level. As a result, the primary objectives and endpoints of this study have been re-formulated. Patients are randomized to 1 of 3 HAART treatment arms: Arm 1: 1 or 2 PIs plus 2 nucleoside reverse transcriptase inhibitors (NRTIs). Arm 2: 1 NNRTI plus 2 NRTIs. Arm 3: 1 or 2 PIs plus an NNRTI plus 1 or 2 NRTIs. Before randomization to a treatment arm, patients are given the option of pre-selecting the drugs they will use or allowing randomization to study-specified drugs. The study-specified PIs are indinavir (IDV), nelfinavir (NFV), or 2 PIs of patient and doctor choice. The study-specified NNRTIs are nevirapine (NVP) or efavirenz (EFV). The choice of NRTIs is decided by the doctor. [AS PER AMENDMENT 9/9/99: The study-specified NRTIs are abacavir (ABC) plus lamivudine (3TC) or didanosine (ddI) plus stavudine (d4T).] This study involves only medical follow-up and evaluation of blood tests; all drugs are obtained by clinician prescription. [AS PER AMENDMENT 9/9/99: ABC and 3TC are provided to all patients who are taking both ABC and 3TC. All patients who are taking either or both ddI and d4T are provided with ddI and/or d4T. All other AR drugs for initial and subsequent treatment regimens are obtained by clinician prescription.] At Months 1 and 4 and then every 4 months thereafter, patients receive a physical examination and questionnaire, and blood samples are drawn to measure CD4 cell count, plasma HIV RNA level, and genotypic antiretroviral resistance. Changes in treatment regimens may occur at any time, and reasons for the changes are recorded.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Expect to be available for at least 6 months of treatment. - Agree to practice abstinence or to use barrier methods of birth control during the study. - Are at least 13 years old (need consent if under 18). Exclusion Criteria Patients will not be eligible for this study if they: - Have ever been on any anti-HIV medications. - Are unable to complete the study for any reason. - Are pregnant or breast-feeding.
Total Enrollment: 1710
Location and Contact Information:
Overall Study Official:
RodgerMacArthur, Study Chair,
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, 06510
United States
Community Consortium / UCSF
San Francisco, California, 94110
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 232980049
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 303081962
United States
Univ TX Health Science Ctr
Houston, Texas, 77030
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York City, New York, 10037
United States
Partners in Research / New Mexico
Albuquerque, New Mexico, 87131
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
United States
Additional Information:
Study ID Numbers: CPCRA 058;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000922
Other Hiv Infections Studies:
1. A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients with AIDS
2. Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids
3. Studies of HIV-1 Infection in Newly Infected Individuals in Southern Africa
4. Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (NOTE: Some Patients Receive Placebo)
5. Health Values and Spirituality in Veterans with HIV/AIDS
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A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)
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