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Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily Clinical research trials and Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily. Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily clinical trial. Participants oftentimes recieve the finest healthcare available for their Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily  Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Merck ,
Synopsis: The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.
Details: Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more. - Are age 16 or older (consent of a parent or guardian required if under 18). - Agree to practice abstinence or use barrier methods of birth control (such as condoms). - Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.) Exclusion Criteria Patients will not be eligible for this study if they: - Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed). - Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV). - Have changed their medications in the last 2 weeks. - Are allergic to IDV, RTV, d4T, or 3TC. - Have used certain medications (see the technical summary for more detail). - Are pregnant or breast-feeding.
Total Enrollment: 80
Location and Contact Information:
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10456
United States
Liberty Med Group
New York City, New York, 10016
United States
Univ of California at San Francisco Gen Hosp
San Francisco, California, 94110
United States
HIV Institute / Davies Med Ctr
San Francisco, California, 94114
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
St Lukes / Roosevelt Hosp / HIV Center
New York City, New York, 10019
United States
Chelsea Village Med Ctr
New York City, New York, 10014
United States
Apogee Med Group
San Diego, California, 92101
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030
United States
Kaiser Foundation Hospital
San Francisco, California, 94118
United States
Mark Watkins
Philadelphia, Pennsylvania, 19107
United States
CRI New England
Brookline, Massachusetts, 02146
United States
SUNY Health Sciences Ctr
Brooklyn, New York, 11203
United States
Montefiore Med Ctr
Bronx, New York, 10467
United States
Additional Information:
Study ID Numbers: 246T; 094-00,CRX463
Study Start Date:
Record last reviewed: July 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002241
Other Hiv Infections Studies:
1. Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox
2. A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly
3. A Phase I Safety and Immunogenicity Trial of the Facilitated HIV-1 gag-pol DNA Vaccine (APL-400-047, Apollon, Inc.) Given Intramuscularly by Needle and Syringe or Biojector 2000 Needle-Free Jet Injection System in HIV-1 Uninfected Adult Volunteers
4. A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis (Diarrhea Caused by the Parasite Cryptosporidium)
5. A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients between Ages 4 and 22 with 7 Drugs, Some at Higher than Usual Doses
Related Studies:
Other HIV Infections Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
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