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The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients Clinical research trials and The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients healthcare trials happen in hundreds of localities 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients. The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients clinical trial. Subjects frequently obtain the most expert healthcare possible for their The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients  The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients
The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the safety and tolerability of hydroxyurea at two doses alone and in combination with didanosine (ddI). To compare the short term antiviral effect of ddI monotherapy versus hydroxyurea plus ddI, as measured by plasma RNA levels at 8 weeks of therapy. [AS PER AMENDMENT 10/1/97: Accrual to arms involving hydroxyurea alone has been closed.] Current antiviral therapies for HIV-1 are limited by a few choices, and the lack of sustained clinical benefit from the drugs. The mechanisms that account for the lack of prolonged inhibition of viral replication by these agents are not fully understood. The activity of RT inhibitors might be potentiated by inhibiting host cellular enzymes essential for efficient HIV reverse transcription. Based on this information, comparisons of the antiviral effects of ddI monotherapy and hydroxyurea plus ddI, with the cellular enzyme ribonucleotide reductase as a potential target, should be done.
Details: Current antiviral therapies for HIV-1 are limited by a few choices, and the lack of sustained clinical benefit from the drugs. The mechanisms that account for the lack of prolonged inhibition of viral replication by these agents are not fully understood. The activity of RT inhibitors might be potentiated by inhibiting host cellular enzymes essential for efficient HIV reverse transcription. Based on this information, comparisons of the antiviral effects of ddI monotherapy and hydroxyurea plus ddI, with the cellular enzyme ribonucleotide reductase as a potential target, should be done. This is a 24-week study, with two 12-week treatment periods. Patients are randomized to one of five treatment arms based upon a patient's history of antiretroviral therapy (naive vs. experienced). The five treatment arms are: 1) ddI plus hydroxyurea placebo. 2) hydroxyurea (lower dose) plus ddI placebo for 4 weeks; then hydroxyurea (higher dose) plus ddI. 3) hydroxyurea (higher dose) plus ddI placebo for 4 weeks; then hydroxyurea (higher dose) plus ddI. 4) hydroxyurea (lower dose) plus ddI. 5) hydroxyurea (higher dose) plus ddI. After the completion of week 12, patients on combination therapy remain on their current therapy and patients on ddI plus placebo have hydroxyurea replace the placebo at 1 of 2 assigned doses (1:1 randomization). AS PER AMENDMENT 5/5/97: If after the 24-week treatment period, a patient has an RNA level less than or equal to 5,000 copies/ml or less than 20,000 copies/ml with a greater than 1 log10 decline from baseline, she has the option to continue therapy open-label ddI plus hydroxyurea for an additional 24 weeks. AS PER AMENDMENT 10/1/97: Accrual to the arms involving hydroxyurea alone has been closed. Patients are randomized to one of the three treatment arms, as follows: 1) hydroxyurea placebo plus ddI. 2) hydroxyurea (lower dose) plus ddI. 3) hydroxyurea (higher dose) plus ddI.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: AS PER AMENDMENT 5/5/97: - PCP prophylaxis with trimethoprim/sulfamethoxazole or Dapsone. Patients must have: - HIV-1 infection. - AS PER AMENDMENT 5/5/97: - CD4 count of 200 - 700 cells/mm3 within 60 days prior to study entry. - AS PER AMENDMENT 10/1/97: - HIV RNA plasma level < 20,000 copies/ml within 60 days of enrollment (obtained at a laboratory certified to perform the Roche Monitor assay). Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: - CMV, MAC, toxoplasmosis, or disseminated fungal infection requiring acute or chronic therapy. - Significant medical illness as determined by investigator. - Active diagnosis of any malignancy, including visceral Kaposi's sarcoma or extensive cutaneous Kaposi's sarcoma for which systemic chemotherapy is anticipated within the next 24 weeks. - Current Grade 2 or greater peripheral neuropathy. Concurrent Medication: Excluded: - Acute or chronic therapy for CMV, MAC, toxoplasmosis, or disseminated fungal infection. AS PER AMENDMENT 5/5/97: - All antiretroviral medications other than those provided on study. - Systemic chemotherapy for active malignancies, including systemic treatment for KS. - Agents with myelosuppressive potential, including tegretol, carboplatin, carmustine, cyclophosphamide and fluorouracil. - Granulocyte colony stimulating factor (G-CSF) except while hydroxyurea or matching placebo is held. Drugs associated with peripheral neuropathy, including: - hydralazine, disulfiram, nitrofurantoin, cisplatinum, diethyldithiocarbamate, gold, rifampin, chloramphenicol, clioquinol, ethambutol, ethionamide, glutethimide, sodium cyanate, and thalidomide. Patients with any of the prior conditions are excluded: - History of transfusion dependent anemia, defined as any history of repeated transfusion with two or more units of red blood cells. - At the discretion of the investigator, history of pancreatitis. Prior Medication: Excluded: - More than 2 weeks prior treatment with ddI. AS PER AMENDMENT 5/5/97: - Other antiretrovirals must be discontinued at least 14 days prior to randomization. - Prior hydroxyurea. - Any candidate HIV vaccine or agent with potential immune modulating effects within the past 30 days. - Any colony stimulating factor or erythropoietin within the past 60 days. Prior Treatment: Excluded: - Transfusion with red blood cells within the past 60 days. Risk Behavior: Excluded: - At the investigator's discretion, any active substance abuse, including alcohol abuse interfering with compliance.
Total Enrollment: 140
Location and Contact Information:
Overall Study Official:
IanFrank, Study Chair, Division of Infectious Diseases, University of Pennsylvania
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Additional Information:
Study ID Numbers: ACTG 307;
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001074
Other Hiv Infections Studies:
1. Alternative Dosing Strategy for Anti-HIV Drugs
2. A Study to Evaluate High Protein Supplementation in HIV-Positive Patients with Stable Weight Loss
3. A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.
4. Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy
5. Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients
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