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A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past Clinical research trials and A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past. A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past clinical trial. Test subjects typically receive the most effective healthcare possible for their A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health 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 Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients. PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.
Details: Patients are randomized to one of four treatment arms: 3TC alone, AZT alone, low-dose 3TC plus AZT, or high-dose 3TC plus AZT. Patients receive treatment for 32 weeks, with possible extension to 52 weeks. PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV positivity. - CD4 count 200-500 cells/mm3. - AZT naive status (<= 4 weeks of prior AZT). Exclusion Criteria Patients with the following prior condition are excluded: History of intolerance to AZT. Prior Medication: Excluded: - More than 4 weeks of prior AZT. - Any prior antiretroviral treatment other than AZT.
Total Enrollment: 320
Location and Contact Information:
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
United States
Montreal Gen Hosp
Montreal, Quebec,
Canada
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860
United States
Ottawa General Hospital
Ottawa, Ontario,
Canada
Advance Community Health Services Inc
Santurce, , 00908
Puerto Rico
Harbor - UCLA Med Ctr
Torrance, California, 90509
United States
Louisiana Cardiovascular Research Ctr
New Orleans, Louisiana, 70119
United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
United States
Pacific Oaks Med Group
Sherman Oaks, California, 91403
United States
CRI of New England
Brookline, Massachusetts, 02445
United States
Nicholaos Bellos
Dallas, Texas, 75246
United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60607
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10019
United States
Combat Group
Los Angeles, California, 90028
United States
Med College of Ohio
Toledo, Ohio, 43699
United States
Richmond AIDS Consortium
Richmond, Virginia, 23219
United States
Wisconsin Community - Based Research Consortium
Milwaukee, Wisconsin, 53202
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Central Texas Med Foundation
Austin, Texas, 78751
United States
Toronto Hosp
Toronto, Ontario,
Canada
San Diego Community Research Group
San Diego, California, 92104
United States
Additional Information:
Study ID Numbers: 129B; NUCA 3001
Study Start Date:
Record last reviewed: May 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002320
Other Hiv Infections Studies:
1. A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides
2. A Placebo-Controlled, Phase I, Pilot Clinical Trial to Evaluate the Safety and Immunogenicity of ENV 2-3, a Yeast-Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 in Individuals With HIV Infection (Placebo patients receive MF59 emulsion only)
3. Use of Muscle Spectroscopy to Evaluate Mitochondrial Dysfunction in HIV-Infected Patients
4. HIV Prevention Counseling for Men Who Have Sex with Men
5. HIV Prevention Preparedness Study
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
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