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A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients Clinical research trials and A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients. A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients clinical trial. Human subjects often get the best healthcare available for their A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients  A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients
A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This study also examines the safety of giving ddI with d4T in the short-term.
Details: Patients are randomized to receive ddI given either qd or bid in combination with d4T given bid (no doses specified).
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented HIV infection. - CD4 cell count of at least 100 cells/mm3. - Plasma HIV RNA count of 10,000 copies/ml or more within 14 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: - Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment. - Bilateral peripheral neuropathy or signs and symptoms of bilateral peripheral neuropathy greater than or equal to Grade 2 at the time of screening. - Inability to tolerate oral medication. - Any other clinical condition that would preclude compliance with dosing requirements. Patients with the following prior conditions are excluded: - History of acute or chronic pancreatitis. - Intractable diarrhea (6 or more loose stools/day for more than 7 consecutive days) within 30 days prior to study entry. - Proven or suspected acute hepatitis within 30 days prior to study entry. 1. Potent neurotoxic drugs, such as vincristine and thalidomide. - Other anti-HIV therapy. 1. Prophylaxis for pneumocystis carinii pneumonia (PCP) is strongly recommended for patients with CD4 cell counts less than or equal to 200/mm3 or who have had a prior episode of PCP. - Immunizations recommended by ACIP for routine practice. - Erythropoietin and G-CSF are allowed if myelosuppression emerges on study. 1. Any antiretroviral therapy. - Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry. 1. Any prior antiretroviral therapy. - Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry. Active alcohol or substance abuse that would prevent adequate compliance or would increase the risk of pancreatitis.
Total Enrollment:
Location and Contact Information:
Univ of Texas Med Branch
Galveston, Texas, 775550835
United States
Medicine Faculty Associates
Ypsilanti, Michigan, 48197
United States
Clinsites / Sorra Research Ctr
Birmingham, Alabama, 35203
United States
Dr Iraj Mirshahi
Richmond, Virginia, 23220
United States
Fanno Creek Clinic
Portland, Oregon, 97219
United States
ID Care Inc
Somerville, New Jersey, 08876
United States
Indiana Univ School of Medicine / Dept of Infect Dis
Indianapolis, Indiana, 46202
United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213
United States
Houston Clinical Research Network
Houston, Texas, 77006
United States
New Jersey Community Research Initiative
Newark, New Jersey, 07103
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Shared Med Research Foundation
Tarzana, California, 91356
United States
Additional Information:
Study ID Numbers: 039D; AI454-143
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002207
Other Hiv Infections Studies:
1. Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents
2. Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.
3. A Study of the Effects of Amprenavir, a Protease Inhibitor, on Carbohydrate and Fat Metabolism in HIV-Infected Patients
4. Reducing the Transmission of HIV in China
5. A Study of Thalidomide in HIV-Infected Patients Who Are Receiving HAART
Related Studies:
Other HIV Infections Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
A Comparison of Two Dose Levels of Didanosine Used in Combination with Stavudine in HIV-Infected Patients
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