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A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002 Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002 Clinical research trials and A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002 healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002. A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002 Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002 clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002 condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002  A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002
A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate the efficacy of AZT versus ddC in terms of survival, antiviral effects, neurological status, and health status in patients post Pneumocystis carinii pneumonia (PCP) who received long-term AZT therapy in ACTG protocol 002 While treatment with AZT has been found to be effective in prolonging survival and reducing the numbers of opportunistic infections in patients with AIDS, during the second year of administration of AZT an acceleration in mortality has been observed. The reasons for this are not known at this time. The study of what may be an AZT-resistant strain of HIV may benefit patients who have been and are still receiving AZT or another drug used in treating HIV ddC. It is hoped that the comparison of the effectiveness of AZT and ddC will benefit in the treatment of these patients.
Details: While treatment with AZT has been found to be effective in prolonging survival and reducing the numbers of opportunistic infections in patients with AIDS, during the second year of administration of AZT an acceleration in mortality has been observed. The reasons for this are not known at this time. The study of what may be an AZT-resistant strain of HIV may benefit patients who have been and are still receiving AZT or another drug used in treating HIV ddC. It is hoped that the comparison of the effectiveness of AZT and ddC will benefit in the treatment of these patients. Following tests to evaluate their health, patients are chosen at random to receive either AZT or ddC. AZT is given by mouth at the patients' current dose. ddC is given by mouth every 8 hours. Treatment continues for up to 12 months. Patients are required to visit the clinic every 2 weeks up to week 12 and then once a month. Blood samples are taken to monitor the safety and effectiveness of treatment.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Required: - Prior zidovudine (AZT) therapy for 9 months. Concurrent Medication: Allowed: - Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP) with aerosolized pentamidine of 300 mg every 4 weeks through the Respirgard II nebulizer. - Maintenance treatment with pyrimethamine, sulfadiazine, amphotericin, fluconazole, ketoconazole, acyclovir, or inhaled pentamidine for subjects who have recovered from toxoplasmosis, cryptococcosis, candidiasis, herpes infection, or PCP. - Dapsone for PCP. - Pyrimethamine-sulfadoxine for toxoplasmosis. - Ganciclovir (DHPG) for maintenance only for cytomegalovirus (CMV) retinitis. - Note: Any approved medications can be used to treat an opportunistic infection. All concurrent medications should be kept to a minimum and recorded. Patients must be positive for HIV by ELISA test and must have been receiving zidovudine (AZT) therapy for at least 9 months and have received AZT within 90 days prior to entry into the study. Patients may be transfusion dependent as long as no more than 3 units of blood are needed in a 21-day period and the hemoglobin does not fall below 6.4 g/dl on two consecutive occasions despite the transfusions. Exclusion Criteria Concurrent Medication: Excluded: - Antiretroviral study medications other than zidovudine (AZT) and biologic response modifiers. - Corticosteroids and chronic aspirin. - Cimetidine. - Flurazepam. - Indomethacin. - Ranitidine. - Probenecid. - Other experimental medications. Patients will be excluded from the study for the following reasons: - Removal from zidovudine (AZT) during treatment on ACTG protocol 002 for recurrent grade 4 toxicity. - Removal from prior dideoxycytidine (ddC) therapy for peripheral neuropathy = or > grade 3. - Visceral or extensive Kaposi's sarcoma requiring therapy or another malignancy requiring therapy. - Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults). Prior Medication: Excluded: - Antiretroviral study medications other than zidovudine (AZT) and biologic response modifiers. - Patients may not have visceral or extensive Kaposi's sarcoma requiring therapy or another malignancy requiring therapy.
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
FischlM, Study Chair,
Univ of Washington
Seattle, Washington, 98105
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania,
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: ACTG 112;
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000682
Other Hiv Infections Studies:
1. A Study to Evaluate the Safety and Effectiveness of a New Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), (+)-Calanolide A, in HIV-Positive Patients Who Have Never Received Anti-HIV Treatment
2. A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation
3. Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
4. A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole
5. A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients between Ages 4 and 22 with 7 Drugs, Some at Higher than Usual Doses
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A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002
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