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Home > "A" Clinical Trials Conditions > A Study to Compare the Safety and Effectiveness of Indinavir Combined with Stavudine and Lamivudine  A Study to Compare the Safety and Effectiveness of Indinavir Combined with Stavudine and Lamivudine
A Study to Compare the Safety and Effectiveness of Indinavir Combined with Stavudine and Lamivudine
For Condition: HIV Infections
Status: Suspended
Sponsor(s): Merck ,
Synopsis: This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.
Details: Patients are randomized to 1 of 4 treatment arms. In Group 1, patients receive a dose of L-756423/IDV once daily plus IDV placebo. In Group 3, patients receive a lower dose of L-756423/IDV twice daily (with the daily dosage equaling that of Group 1) plus IDV placebo. In Groups 2 and 4, patients receive equal dosages of IDV plus L-756423/IDV placebo. In all 4 groups L-756423 and IDV are blinded to the investigator and patient. All groups receive open-label d4T and 3TC. Patients routinely undergo a physical exam and have blood and urine tests to ensure the drugs' safety and tolerability, which will be evaluated by tabulation of adverse events and clinical assessment of laboratory data. In addition, CD4+ T cell and plasma viral RNA levels are measured to quantify the drugs' antiretroviral activity.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this trial if you: - Have HIV infection. - Have levels of CD4 cells of 100 cells/mm3 or greater. - Have a viral load of 10,000 copies/ml or greater. - Are 18 years of age or older. Exclusion Criteria You may not be eligible for this trial if you: - Have ever taken anti-HIV drugs.
Total Enrollment: 186
Location and Contact Information:
Univ of Kentucky
Lexington, Kentucky, 40536
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
SUNY at Stony Brook / Div of Infectious Disease
Stony Brook, New York, 117948153
United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536
United States
Associates in Research
Ft. Myers, Florida, 33901
United States
The Miriam Hosp
Providence, Rhode Island, 02906
United States
NYU Med Ctr / C & D Building
New York City, New York, 10016
United States
Grady Mem Hosp
Atlanta, Georgia, 30308
United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York City, New York, 10021
United States
UCLA School of Medicine / Ctr for Research and Education
Los Angeles, California, 900951793
United States
The CORE Ctr
Chicago, Illinois, 60612
United States
ViRx / Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009
United States
Additional Information:
Study ID Numbers: 300B; 009-01,009-00
Study Start Date:
Record last reviewed: April 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002424
Other Hiv Infections Studies:
1. Study of a New Protease Inhibitor, BMS-232632, in Combination with Other Anti-HIV Drugs
2. A Study of T-20 in HIV-Positive Adults
3. Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy
4. A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma
5. Adding New Drugs for HIV Infected Patients Failing Current Therapy
Related Studies:
Other HIV Infections Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
A Study to Compare the Safety and Effectiveness of Indinavir Combined with Stavudine and Lamivudine
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