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A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine 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 A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine Clinical research trials and A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine 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 A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine. A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine 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 A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine clinical trial. Human subjects often receive the most effective healthcare possible for their A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine 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 > "A" Clinical Trials Conditions > A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine  A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine
A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine
For Condition: AIDS-Related Complex,Acquired Immunodeficiency Syndrome
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Several dideoxynucleosides have now been shown to have activity against HIV but to have different toxicities. This study will involve therapy of patients with AIDS or ARC with two of these agents, AZT and 2', 3'-dideoxyinosine (ddI), which have different toxicity profiles, over a 2-year period of time. The rationale for using the two drugs will be to reduce toxicity and also possibly to delay or prevent the development of resistance. Patients will be randomized to receive either an alternating regimen or a continuous simultaneous regimen with these two drugs. The study will be structured as a randomized pilot study.
Details: Several dideoxynucleosides have now been shown to have activity against HIV but to have different toxicities. This study will involve therapy of patients with AIDS or ARC with two of these agents, AZT and 2', 3'-dideoxyinosine (ddI), which have different toxicity profiles, over a 2-year period of time. The rationale for using the two drugs will be to reduce toxicity and also possibly to delay or prevent the development of resistance. Patients will be randomized to receive either an alternating regimen or a continuous simultaneous regimen with these two drugs. The study will be structured as a randomized pilot study.
Eligibility:
Study Type: Interventional, Treatment, Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients with AIDS or symptomatic HIV infection who have 10-350 CD4+ T cells per mm(3) and an estimated life-expectancy of over 3 months. For the purpose of this study, a patient is defined as having symptomatic HIV infection if he or she has a history of or has active thrush (oral candidiasis); a history of or active oral hairy leukoplakia; herpes zoster within the last 3 years; recurrent seborrheic dermatitis or puritic folliculitis; weight loss of 4.5 kg or 10 percent of body weight not caused by dieting; unexplained intermittent diarrhea (2 or more liquid stools per day) within the last 4 months; night sweats; mild cognitive impairment; or fatigue interfering with activity within the past 6 months. Lymphadenopathy will not, in itself, be considered as sufficient for being considered as having symptomatic HIV infection. All patients must have serum antibodies to HIV, ambulatory status, and capacity to give informed consent. No prior use of dideoxynucleoside therapy (including but not restricted to AZT, ddC, or ddI) for over 3 months. However, preference will be given to patients who have received them for 1 month or less. No pregnancy or the possibility of becoming pregnant during drug administration. Female patients of child-bearing age must have a negative pregnancy test just prior to enrollment and agree to practice birth control while on the protocol. No past or present evidence of renal disease (CRC1 estimated or determined to be less than 50 ml/min/1.73 m2). Patients will be excluded if they have any one of the following hematologic abnormalities: Hb less than 10.0 gm per dl or transfusion within the last month, or WBC less than 2000 per mm(3) or Platelets less than 75,000 per mm(3). No history of hepatic cirrhosis or present hepatic dysfunction with: Total bilirubin greater than 3.0 mg per dl (2x the upper limit of normal). Alkaline phosphatase greater than 372 U per l (3x the upper limit of normal). AST/GOT greater than 132 U per l (3x the upper limit of normal). No evidence of severe diarrhea (over 5 stools per day), an underlying severe infection (including CMV retinitis, colitis, or pneumonitis); or evidence of Kaposi's sarcoma or other tumor which is likely to require specific anti-tumor therapy within 24 months of entering the study: As a practical matter, only patients with Kaposi's sarcoma who have a few cutaneous lesions with no mucosal or internal lesions will be eligible. Patients will be ineligible if they have some evidence of active life-threatening infections with bacterial, viral, fungal, or protozoan pathogens at the time of entry into the study. In general, patients who have had a fever of 39 degrees Celsius within the past 10 days will in general be ineligible unless it is apparent that this is not the result of a severe underlying infection. No known hypersensitivity reactions to or major toxicities from AZT or ddI. (This would include anaphylaxis reactions, hives, or Stevens Johnson syndrome, but would not include the minor rash occasionally seen with ddI.) Patients must be willing to give informed consent, attend the outpatient clinic, and refrain from unprotected sexual contact or other activities which may result in re-infection with HIV. Present use of illicit drugs (for example, heroin or cocaine) or ingestion of substantial alcohol (enough to increase the risk of pancreatitis) will exclude the patient from the study. No evidence of underlying cardiac disease, history of pancreatitis, or peripheral neuropathy. No treatment within the last 4 months with suramin, treatment within the last 3 months with ribavirin, or treatment within the past 4 weeks with any anti-retroviral drug, cytotoxic chemotherapeutic agents, steroids, interferon, or immunomodulating agents.
Total Enrollment: 42
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 910018; 91-C-0018
Study Start Date: October 30, 1990
Record last reviewed: August 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001267
Other Acquired Immunodeficiency Syndrome Studies:
1. A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine
2. Pulmonary Complications of HIV Infection Study (PACS)
Related Studies:
Other Acquired Immunodeficiency Syndrome Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex with an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine
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