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The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection 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 The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection Clinical research trials and The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection 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 The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection. The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection 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 The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection clinical trial. Test subjects oftentimes recieve the best healthcare possible for their The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection 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 > "T" Clinical Trials Conditions > The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection  The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection
The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection
For Condition: HIV Infections
Status: Completed
Sponsor(s): Merck Research Laboratories ,
Synopsis: To evaluate the ability of the combination of indinavir, zidovudine, and lamivudine to suppress HIV-1 infection as measured by: (1) the maintenance of HIV-1 serum viral RNA below the limit of detection of the most sensitive validated assay (ultradirect assay) and (2) absence of evidence of infectious virus in lymph node, cerebrospinal fluid (CSF), peripheral mononuclear cells (PBMCs), and semen. It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will result in: 1. No evidence of infectious virus in lymph node tissue, CSF, PBMCs, and semen samples in 50% of patients who have undetectable viral RNA by the most sensitive validated assay available (ultradirect assay) for at least 48 weeks. 2. Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the ultradirect assay for at least 48 weeks in at least 25% of patients. 3. Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the standard Amplicor assay (i.e., negative) in at least 90% of patients by Week 16. 4. Suppression of HIV-1 infection, suggesting eradication of the virus as measured by maintenance of serum viral RNA to below the limit of detection of the ultradirect assay for at least 24 weeks after discontinuation of indinavir, zidovudine, and lamivudine in patients who have maintained this level of suppression for at least 120 weeks on therapy.
Details: It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will result in: 1. No evidence of infectious virus in lymph node tissue, CSF, PBMCs, and semen samples in 50% of patients who have undetectable viral RNA by the most sensitive validated assay available (ultradirect assay) for at least 48 weeks. 2. Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the ultradirect assay for at least 48 weeks in at least 25% of patients. 3. Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the standard Amplicor assay (i.e., negative) in at least 90% of patients by Week 16. 4. Suppression of HIV-1 infection, suggesting eradication of the virus as measured by maintenance of serum viral RNA to below the limit of detection of the ultradirect assay for at least 24 weeks after discontinuation of indinavir, zidovudine, and lamivudine in patients who have maintained this level of suppression for at least 120 weeks on therapy. All patients receive indinavir plus zidovudine plus lamivudine for at least 96 weeks. If there is no evidence of infectious virus, and patients continue to have serum viral RNA levels below the limit of detection of the ultradirect assay for at least 96 weeks, therapy is continued for an additional 24 weeks. However, during this additional 24 weeks of therapy patients may continue to receive this triple combination drug regimen or make changes to this drug regimen treatment by reducing their number of antiretroviral agents. After 120 weeks, if patients continue to have serum viral RNA levels below the limit of detection of the ultradirect assay, patients discontinue all antiretroviral therapy. However, if there is any evidence of infectious virus, as outlined above, patients do not discontinue therapy. Patients who develop detectable serum viral RNA following discontinuation of therapy are given the option to reinitiate therapy with the triple combination of indinavir, zidovudine and lamivudine. NOTE: Patients who develop an intolerance to zidovudine may use stavudine at doses per body weight at the direction of the investigator.
Eligibility:
Study Type: Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV-1 seropositive status. - CD4 count >= 500 cells/mm3. - Serum viral RNA level > 1000 copies/ml. Exclusion Criteria Prior Medication: Excluded: Previous antiretroviral therapy.
Total Enrollment: 200
Location and Contact Information:
Montreal Gen Hosp
Montreal, Quebec,
Canada
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
NYU Med Ctr
New York City, New York, 10016
United States
LAC - USC Med Ctr
Los Angeles, California, 90033
United States
Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit
Stony Brook, New York, 117948153
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, 06510
United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942050
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115
United States
Fenway Community Health Ctr
Boston, Massachusetts, 02115
United States
Rush Presbyterian - Saint Luke's Med Ctr / Infect Dis
Chicago, Illinois, 606123832
United States
Saint Paul's Hosp
Vancouver, British Columbia,
Canada
Pitt Treatment Ctr
Pittsburgh, Pennsylvania, 15213
United States
Beth Israel Deaconess Med Ctr - East Campus
Boston, Massachusetts, 02215
United States
AIDS Community Research Consortium
Redwood City, California, 94063
United States
Additional Information:
Study ID Numbers: 246G; MK-0639
Study Start Date:
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002179
Other Hiv Infections Studies:
1. Study of Anti-HIV Therapy Intensification
2. A Study of AS-101 in Patients with AIDS or AIDS Related Complex (ARC)
3. The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
4. The Safety and Effectiveness of Rifabutin, Combined with Clarithromycin or Azithromycin, in HIV-Infected Patients
5. A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time
Related Studies:
Other HIV Infections Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials
The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection
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