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Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children Clinical research trials and Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children. Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children clinical trial. Participants frequently get the best healthcare available for their Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children  Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected children. IDV will be given either as a powder mixed into applesauce or as capsules given on an empty stomach.
Details: In this multicenter, open-label study patients receive a combined drug regimen of indinavir, stavudine, and lamivudine over 48 weeks. Patients are evaluated at Weeks 0, 2, 4, every 4 weeks until Week 24, and every 8 weeks thereafter until study completion. [AS PER AMENDMENT 4/27/99: The study has been extended for an additional 48 weeks for a total of 96 weeks.]
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 3 Years/15 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Your child may be eligible for this study if he/she: - Is 3 - 15 years old and has consent of a parent or legal guardian who is able to return with the child for follow-up visits. - Is HIV-positive. - Is generally healthy. - Is able to swallow medication in capsule form. - Has never taken d4T or has never taken 3TC. - Agrees to use barrier methods of birth control (such as condoms) during the study. The pill is not allowed during the study. Exclusion Criteria Your child will not be eligible for this study if he/she: - Has a serious infection at the time of study entry. - Has a history of severe diarrhea. - Is unable to take any of the medications in this study for any reason. - Has a history of certain serious illnesses. - Has taken any protease inhibitors (PIs). - Has taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz (EFV), within 2 weeks prior to study entry. - Has taken certain medications. - Is pregnant or breast-feeding.
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
JohnSleasman, Study Chair,
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Univ of Florida Gainesville
Gainesville, Florida, 32610
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Additional Information:
Study ID Numbers: ACTG 395;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000901
Other Hiv Infections Studies:
1. Antiviral Activity of and Resistance to Lamivudine in Combination with Zidovudine, Stavudine, or Didanosine
2. Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
3. Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
4. A Study of Treatments for Fungal Infections of the Mouth and Throat in HIV-Infected Patients Who Have Had Success with Itraconazole But Not with Fluconazole
5. Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia
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Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
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