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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 Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about 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 website 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 health trials occur in a lot of of places throughout 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as 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 volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes 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. Human subjects frequently get 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. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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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. Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals
2. A Study of the Side Effects of L-743,872 in Men with Candidal Esophagitis
3. Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3
4. The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Children with AIDS
5. A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies
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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
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