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The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection Clinical research trials and The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection. The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection clinical trial. Human subjects often receive the most effective healthcare possible for their The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection  The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection
The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection
For Condition: HIV Infections
Status: Completed
Sponsor(s): Parexel ,
Synopsis: To evaluate the tolerance and immunologic and virologic effects of multidrug combinations of antiretrovirals in patients with HIV infection. Specifically, to evaluate zidovudine/zalcitabine ( AZT / ddC ) alone or in combination with either nevirapine or saquinavir ( Ro 31-8959 ). Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available.
Details: Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available. Patients are randomized to receive AZT/ddC either alone or in combination with nevirapine or Ro 31-8959 for a minimum of 48 weeks. Patients are followed at weeks 2 and 4 and every 4 weeks thereafter.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Encouraged: - PCP chemoprophylaxis for patients whose CD4 count falls below 200 cells/mm3 or who develop PCP on study. Allowed: - Secondary prophylaxis with nonexperimental agents in patients who develop TB, Mycobacterium avium-intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection. - Acyclovir for 21 days or less for acute treatment. - Recombinant erythropoietin and G-CSF for grade 3 or worse anemia and neutropenia, respectively. Patients must have: - HIV infection. - CD4 count 200 - 500 cells/mm3. - No prior antiretroviral therapy. - Life expectancy of at least 48 weeks. - Consent of parent or guardian if less than 18 years of age. NOTE: - Participating centers are encouraged to enroll female patients. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Any grade 3 or greater toxicity. - Symptoms of peripheral neuropathy. - Malabsorption or severe chronic diarrhea. - Inability to eat at least one meal daily because of chronic nausea, emesis, or abdominal or esophageal discomfort. Concurrent Medication: Excluded during the first 28 days of nevirapine administration: - Augmentin and other antibiotics containing clavulanic acid. Excluded at any time: - Dicumarol, warfarin, and other anticoagulant medications. - Tolbutamide. - Cimetidine. - Erythromycin. Patients with the following prior conditions are excluded: - History of acute or chronic pancreatitis. - History of grade 2 or worse peripheral neuropathy from any cause. Prior Medication: Excluded: - Any prior antiretroviral therapy. Excluded within 4 weeks prior to study entry: - Immunomodulating agents such as systemic corticosteroids, IL-2, alpha-interferon, beta-interferon, or gamma-interferon. - Immunotherapeutic vaccines. - Cytotoxic chemotherapy. - Erythromycin. - Dicumarol, Coumadin / warfarin, and other anticoagulant medications. - Phenobarbital. - Amoxicillin / clavulanate. - Ticarcillin / clavulanate. - Tolbutamide. - Erythromycin. - Cimetidine. Prior Treatment: Excluded within 4 weeks prior to study entry: - Non-local radiation therapy. Current alcohol or illicit drug use that would interfere with ability to comply with study requirements.
Total Enrollment: 225
Location and Contact Information:
PAREXEL Intl Corp / InterCo Collaboration Ctr
Waltham, Massachusetts, 02154
United States
Additional Information:
Study ID Numbers: 229C; ICC 001
Study Start Date:
Record last reviewed: June 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002347
Other Hiv Infections Studies:
1. The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients
2. A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
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. A Study of Letrazuril in the Treatment of AIDS-Related Diarrhea
5. A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients without Previous Anti-HIV Drug Therapy
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Waltham Clinical Trials
The Safety and Effectiveness of Retrovir Plus HIVID Combined with Either Nevirapine or Invirase in the Treatment of HIV Infection
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