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The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs Clinical research trials and The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs. The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs clinical trial. Subjects typically recieve the finest healthcare available for their The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs  The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: To evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally in combination with zidovudine, lamivudine, or stavudine in HIV-infected patients with CD4 cell counts >= 100 cells/mm3 and an HIV-1 RNA baseline copy number >= 5000 copies/ml. To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (500 copies/ml) by 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20. To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24.
Details: This protocol is a stratified, randomized, open-label study of the safety and efficacy of adefovir dipivoxil with indinavir as quadruple therapy in combination with zidovudine and lamivudine, or as triple combination administered with either zidovudine or lamivudine or stavudine for 48 weeks in the treatment of HIV-infected patients with CD4 cell counts >= 100/mm3 and an HIV-1 RNA baseline copy number >= 5000 copies/ml. Patients will be randomized to adefovir dipivoxil, indinavir, zidovudine, and lamivudine or adefovir dipivoxil, indinavir, and a nucleoside inhibitor (randomly assigned to receive zidovudine, lamivudine, or stavudine) or to indinavir, zidovudine, and lamivudine. Additionally, a daily dose of L-carnitine will be administered to all patients randomized to an arm containing adefovir dipivoxil.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Laboratory diagnosis of HIV infection (positive HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA, or HIV-1 culture). - An HIV-1 RNA plasma titer >= 5000 copies/ml within 14-21 days prior to the baseline visit. - CD4 cell count >= 100 cells/mm3 within 14-21 days prior to the baseline visit. - A minimum life expectancy of at least 1 year. - Signed, informed consent from parent or legal guardian for those patients < 18 years of age. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms and conditions are excluded: - Active, serious infections (other than HIV infection) requiring parenteral antibiotic or antiviral therapy. Patients will be considered recovered from such infectious episodes if at least 2 weeks elapsed following the cessation of parenteral therapy before the baseline visit. - Exhibiting evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication. - Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Patients with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 4 weeks prior to baseline and are not anticipated to require systemic therapy during the study. - Any other clinical condition that in the opinion of the investigator would make the patient unsuitable for study or unable to comply with the dosing requirements. Patients with any of the following prior conditions are excluded: - A new AIDS-defining event diagnosed within 1 month prior to baseline. - Any patient who has previously been discontinued from zidovudine, lamivudine, and/or stavudine due to a drug-related toxicity. - Significant history of peripheral neuropathy. 1. Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons. - Saquinavir, ritonavir, nelfinavir, nevirapine, delavirdine, didanosine, dideoxycytidine, interferon alpha, interferon beta, isoniazid, rifampin, investigational agents (except upon Sponsor approval), chemotherapeutic agents (systemic), terfenadine, astemizole, cisapride, triazolam, and midazolam. 1. Prior use of adefovir dipivoxil. - Prior non-protease antiretroviral therapy (other than antiretroviral vaccines) for greater than 4 cumulative weeks. - Prior use of any antiretroviral protease inhibitor. - Immunizations within 30 days of baseline. - Antiretroviral vaccine therapy within 60 days of baseline. - Treatment in the 4 weeks prior to baseline, with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons. - Any other investigational drug within 30 days prior to baseline. - Any prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements. Patients with current alcohol or substance abuse judged by the investigator to potentially interfere with patient compliance.
Total Enrollment: 100
Location and Contact Information:
AIDS Healthcare Foundation Labs
Los Angeles, California, 90027
United States
Hosp Regional de Ponce - Area Vieja
Ponce, , 00731
Puerto Rico
Saint Vincent's AIDS Ctr
New York City, New York, 10011
United States
George Washington Med Ctr
Washington D.C., District of Columbia, 20037
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Hershey Med Ctr / Dept of Hematology
Hershey, Pennsylvania, 17033
United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21287
United States
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860
United States
Community Research Initiative on AIDS
New York City, New York, 10001
United States
Phoenix Body Positive
Phoenix, Arizona, 85016
United States
Blick Med Associates
Greenwich, Connecticut, 06830
United States
Swedish Med Ctr
Seattle, Washington, 98122
United States
Community Research Initiative
Brookline, Massachusetts, 02445
United States
Davies Med Ctr
San Francisco, California, 94114
United States
Cook County Gen Hosp / Division of Infect Diseases
Chicago, Illinois, 60612
United States
Additional Information:
Study ID Numbers: 232D;
Study Start Date:
Record last reviewed: October 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002379
Other Hiv Infections Studies:
1. Effects of home visits on medication adherence in children and youth with HIV
2. A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
3. A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects
4. The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease
5. Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
Related Studies:
Other HIV Infections Clinical Trials
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Other San Francisco Clinical Trials
The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined with Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
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