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A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC Clinical research trials and A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC. A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC clinical trial. Participants typically obtain the most effective healthcare available for their A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

Home > "A" Clinical Trials Conditions > A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC

A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC



A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC

For Condition: HIV Infections
Status: Completed
Sponsor(s): Merck Research Laboratories ,
Synopsis: To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.
Details: Patients are randomized to 1 of 2 arms: Arm A: Indinavir plus ZDV plus 3TC. Arm B: Indinavir (test dose) plus ZDV plus 3TC. NOTE: d4T may be substituted for zidovudine for toxicity management. Patients are stratified based on prior use of nucleoside analogs (naive vs experienced to ZDV, dideoxyinosine [ddI], dideoxycytidine [ddC], and d4T) and screening viral RNA results (lower than 50,000 copies/mL vs more than 50,000 copies/mL).
Eligibility:
Study Type:
  Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV-1 seropositive status. - CD4 count greater than 100 cells/mm3. - Viral RNA above 10,000 copies/mL. - Consent from parent or guardian if less than 18 years of age. Exclusion Criteria Prior Medication: Excluded: - Prior therapy with protease inhibitors. - Prior therapy with 3TC.
Total Enrollment: 400

Location and Contact Information:

Washington Univ
St. Louis,  Missouri,  63108
United States
 

AIDS Research Consortium of Atlanta
Atlanta,  Georgia,  30308
United States
 

LAC/USC Med Ctr
Los Angeles,  California,  90033
United States
 

Pittsburgh Treatment Ctr / Univ of Pittsburgh
Pittsburgh,  Pennsylvania,  15261
United States
 

Brown Univ / Miriam Hosp
Providence,  Rhode Island,  02906
United States
 

Georgetown Univ Med Ctr
Washington D.C.,  District of Columbia,  20007
United States
 

Wilmington Hosp / Med Ctr of Delaware
Wilmington,  Delaware,  19899
United States
 

Kaiser Med Ctr
San Francisco,  California,  94110
United States
 

Johns Hopkins Hosp
Baltimore,  Maryland,  21287
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  352942050
United States
 

Allegheny Univ Hosp
Philadelphia,  Pennsylvania,  19129
United States
 

Vanderbilt Univ Med Ctr
Nashville,  Tennessee,  372321302
United States
 

Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit
Stony Brook,  New York,  117948153
United States
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

Univ of Washington / AIDS Clinical Trial Unit
Seattle,  Washington,  98104
United States
 


Additional Information:
Study ID Numbers:
  246M;  069-00
Study Start Date: 
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002208

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