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The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine Clinical research trials and The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine medical trials happen in hundreds of localities throughout the U.S.A.. 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 does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine. The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine clinical trial. Participants frequently obtain the most expert healthcare available for their The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine  The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine
The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.
Details: Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain >= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - At least six months of prior cumulative ZDV therapy. - Qualifying plasma HIV RNA count of >= 4 log10 copies/ml obtained within 2 weeks of randomization. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: - Presence of newly diagnosed AIDS defining opportunistic infection requiring acute therapy at time of enrollment. - Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days). - Signs and symptoms of bilateral peripheral neuropathy >= grade 2 at the time of screening. - Inability to tolerate oral medication. - Any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements. Concurrent Medication: Excluded: - Therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential. - Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole at any time while on indinavir therapy. Patients with any of the following prior conditions or symptoms are excluded: - History of acute or chronic pancreatitis. - Prior history of bilateral peripheral neuropathy. - Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days) within 30 days prior to study entry. Prior Medication: Excluded: - Any prior antiretroviral therapy except for ddI, ddC, 3TC or ZDV (for ZDV, as specified in inclusion criteria). - Previous therapy with agents with significant systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start. - Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole within 2 weeks prior to starting indinavir. - Any other prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing regimen. Risk Behavior: Excluded: - Active alcohol abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy or to increase the risk of developing pancreatitis. Required: At least 6 months of prior cumulative ZDV therapy.
Total Enrollment: 80
Location and Contact Information:
Univ of South Florida
Tampa, Florida, 33612
United States
SUNY at Stony Brook / Division of Infectious Diseases
Stony Brook, New York, 11794
United States
Sunnybrook Health Science Ctr
North York, Ontario,
Canada
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Houston Clinical Research Network / Div of Montrose Clinic
Houston, Texas, 77006
United States
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec,
Canada
Univ of Utah / School of Medicine / Div of Infect Dis
Salt Lake City, Utah, 84132
United States
Univ of Puerto Rico School of Medicine
San Juan, , 00927
Puerto Rico
Additional Information:
Study ID Numbers: 244B; AI455-048
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002371
Other Hiv Infections Studies:
1. A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects
2. Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
3. A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3
4. Evaluation of the Epidermal Langerhans Cell Population in AIDS / ARC Patients by the Topical Application of a Potent Contact Allergen (1-Chloro-2,4-Dinitro-Chlorobenzene) (DNCB)
5. An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection
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The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine
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