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Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Clinical research trials and Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients health trials take place in a lot of of cities across the US. 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 / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients. Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients  Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients
Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Gilead Sciences , Bristol-Myers Squibb,Glaxo Wellcome,Dupont Pharmaceuticals
Synopsis: The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
Details: Patients receive a treatment regimen of adefovir dipivoxil, didanosine, efavirenz, and lamivudine for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA and lymphocyte subsets and for the development of adverse experiences and laboratory toxicities. At Weeks 8, 12, 24, and 48, patients are assessed for adherence to study treatment with a questionnaire. Patients who experience virologic failure are discontinued from the study. Patients who experience treatment intolerance may have their antiretroviral treatment regimens changed. After Week 48, patients with documented virologic response are eligible to continue receiving study treatment.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Are at least 13 years old (need consent of parent or guardian if under 18). - Have an HIV count of 5,000 copies/ml or more within 30 days prior to study entry. - Have a CD4+ count of 50 cells/mm3 or more. Exclusion Criteria You will not be eligible for this study if you: - Are diagnosed with hepatitis within 30 days prior to study entry. - Have certain serious medical conditions, including an AIDS-defining clinical condition. - Received chemotherapy or radiation therapy within 30 days of study entry. - Have taken any nucleoside reverse transcriptase inhibitors (NRTIs) for more than 2 weeks. - Have ever taken 3TC. - Have ever taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs). - Have taken medications that affect your immune system within 30 days prior to study entry. - Have received a vaccine within 30 days prior to study entry. - Are enrolled in another anti-HIV drug study while participating in this study. - Abuse alcohol or drugs. - Are pregnant or breast-feeding.
Total Enrollment: 25
Location and Contact Information:
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Univ of Colorado / Health Science Ctr
Denver, Colorado, 80262
United States
Brown Univ School of Medicine
Providence, Rhode Island, 02908
United States
Pacific Oaks Med Group
Beverly Hills, California, 90211
United States
Additional Information:
Study ID Numbers: 232J; ICC 604
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002234
Other Hiv Infections Studies:
1. A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
2. A Study of Zidovudine in HIV-Infected Patients with Kidney Problems
3. A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
4. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies
5. T-20 in HIV Patients with Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs
Related Studies:
Other HIV Infections Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials
Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients
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