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A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease 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 Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease Clinical research trials and A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease 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 Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease. A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease 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 Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease 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 Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease  A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease
A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the long-term safety and tolerance of four alternating and two intermittent regimens of zidovudine ( AZT ) and 2',3'-dideoxycytidine ( zalcitabine; ddC ) in the treatment of patients with advanced HIV disease who have had to discontinue AZT because of true hematologic intolerance to standard reduced doses of AZT. AIDS is a serious infectious disease caused by a new family of retrovirus which is spread primarily through sexual contact and administration of blood or blood products. Individuals who are infected with HIV could therefore benefit from therapy with an effective anti-AIDS virus agent. AZT and ddC have both been tested as antiviral agents and their potentially beneficial effects may be limited by time- and dose-dependent toxicity. A combination regimen using shorter courses of AZT and ddC might therefore be able to sustain treatment without producing toxicity. In addition, since the two drugs exhibit their major toxicity on different organ systems, cumulative or additive toxicity would not be expected.
Details: AIDS is a serious infectious disease caused by a new family of retrovirus which is spread primarily through sexual contact and administration of blood or blood products. Individuals who are infected with HIV could therefore benefit from therapy with an effective anti-AIDS virus agent. AZT and ddC have both been tested as antiviral agents and their potentially beneficial effects may be limited by time- and dose-dependent toxicity. A combination regimen using shorter courses of AZT and ddC might therefore be able to sustain treatment without producing toxicity. In addition, since the two drugs exhibit their major toxicity on different organ systems, cumulative or additive toxicity would not be expected. There are six study regimens. Four of these are alternating regimens: A 2-week cycle consisting of 1 week of AZT followed by 1 week of ddC and an 8-week cycle consisting of 4 weeks of AZT followed by 4 weeks of ddC. All patients on alternating regimens will receive AZT alone at the standard dose orally every 4 hours for either 1 or 4 weeks. After the AZT is stopped, patients receive ddC orally every 4 hours for either 1 or 4 weeks, which completes a treatment cycle. One of two doses of ddC is studied in each alternating regimen. Both doses must be tested because the optimal dose cannot be inferred from tests that have already been done. AZT is administered first in the hope that AZT-mediated reduction of p24 antigen load may reduce the occurrence of acute ddC toxicity. Two intermittent regimens are also studied and are included to assess the contribution of each drug in the alternating regimens. One program consists of 1 week of AZT followed by 1 week of no drug. The other consists of 1 week of ddC followed by 1 week of no drug. Drug dosing continues for a total of 48 weeks unless toxicity develops. Patients who complete 48 weeks of therapy are followed for 4 additional weeks off therapy. Patients removed from study because of toxicity are followed for 4 weeks or until toxicity resolves. If study participants complete 48 weeks of therapy and meet criteria for efficacy, the study drug regimen may be continued for an additional 32 weeks. A 4 week wash-out period off drug will not be required for patients continuing on study. AMENDED 09/24/90 Drug dosing will be discontinued as of 11/30/90.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Aerosolized pentamidine at prophylactic doses, but its use is discouraged in persons without a history of Pneumocystis carinii pneumonia (PCP). - Acyclovir for acute disseminated zoster. - Maintenance doses of pyrimethamine, amphotericin, and pentamidine are allowed for patients who recover from toxoplasmosis, cryptococcosis, or pneumocystosis acquired after study entry. Patients included in the study must have HIV infection confirmed by ELISA test and must have a documented history of at least 4 weeks of zidovudine (AZT) treatment. - While hemoglobin at the start of AZT therapy must have been = or > 9.5 g/dl and granulocyte count = or > 1200 cells/mm3 at the start of AZT therapy, hematologic toxicity due to a reduced dose of AZT will be defined as: - Hematologic toxicity must have occurred during a period when AZT was administered at = or < 600 mg/day for at least 2 weeks. - There must have been no evidence of a cause for toxicity other than HIV infection and AZT use. - Hematologic intolerance may have consisted of hemoglobin toxicity, granulocyte toxicity, or both. - Recovery from hematologic toxicity must be manifested by the presence of a granulocyte count of > 1000 cells/mm3 and a hemoglobin of > 9.5 g/dl. without transfusions during the preceding 4 weeks. Patients must also have no significant bilateral symptoms of peripheral neuropathy, although all patients may have any degree of stable unilateral neurologic deficit. Up to 24 patients may have certain moderate bilateral abnormalities of peripheral neuropathy. AZT may not have been administered within 14 days prior to entering the study. Prior Medication: Required: - A documented history of at least 4 weeks of zidovudine treatment which resulted in hematologic toxicity at reduced dose. - Allowed but discouraged: - A1-721. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Known active AIDS opportunistic infections. - Known mycobacteremia, although cultures may be pending at the time of enrollment. - Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study or with concurrent neoplasms other than KS, basal cell carcinoma of the skin or in situ carcinoma of the cervix. - Significant malabsorption as manifested by steatorrhea with greater than 10 percent weight loss within the last 3 months. - Diabetes. Concurrent Medication: Excluded: - Experimental medications. - Aspirin. - Acetaminophen. - Nonsteroidal anti-inflammatory agents should be minimized, with continuous use for > 72 hours discouraged. - Chronic suppressive anti-infective therapy other than inhaled pentamidine and neurotoxic drugs should be avoided. - Continuous therapy for > 7 days of acyclovir is prohibited except for the acute treatment of disseminated herpes zoster infection. Patients with the following are excluded: - Known mycobacteremia, although cultures may be pending at the time of enrollment. - Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study or with concurrent neoplasms other than KS, basal cell carcinoma of the skin or in situ carcinoma of the cervix. - Significant malabsorption as manifested by steatorrhea with greater than 10 percent weight loss within the last 3 months. - Diabetes. - Known active AIDS opportunistic infections. Patients must also have no significant bilateral symptoms of peripheral neuropathy, although all patients may have any degree of stable unilateral neurologic deficit. Up to 24 patients may have certain moderate bilateral abnormalities of peripheral neuropathy. AZT may not have been administered within 14 days prior to entering the study. Prior Medication: Excluded within 30 days of study entry: - Any antiretroviral agents except zidovudine (AZT). - Discouraged: - A1-721. - Pentamidine at prophylactic doses in persons without a history of Pneumocystis carinii pneumonia (PCP). Active substance and/or alcohol abuse.
Total Enrollment: 96
Location and Contact Information:
Overall Study Official:
SBozzette, Study Chair,
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Additional Information:
Study ID Numbers: ACTG 050;
Study Start Date:
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000719
Other Hiv Infections Studies:
1. A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)
2. A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
3. A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients with AIDS
4. A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers
5. Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients with Tuberculosis
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A Trial of Alternating 2',3'-Dideoxycytidine and Zidovudine in the Treatment of Patients With Advanced HIV Disease
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