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Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children Clinical research trials and Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children. Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children clinical trial. Human subjects often get the best healthcare available for their Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children  Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Gilead Sciences ,
Synopsis: The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.
Details: During the first phase of the study (Days 1-6), the safety and tolerability of multiple doses of ADF is assessed when administered simultaneously with the patient's reverse transcriptase inhibitor (RTI) regimen. The second phase begins on Day 7 when nelfinavir is added to the therapy regimen for an additional 15 weeks. ADF pharmacokinetics are measured on Days 1, 2, and 7 (on a subset of 18 patients); peak and trough samples are collected on Day 28.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 3 Months/16 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Your child may be eligible for this study if he/she: - Is 3 months to 16 years old. - Is HIV-positive. - Has never taken protease inhibitors or has previously taken ritonavir (RTV), saquinavir (SQV), or indinavir (IDV) and is willing to stop the medication at study entry. - Is taking an anti-HIV drug combination that will not change during at least the 2 weeks prior to study entry. - Agrees to use effective barrier methods of birth control, such as condoms, during the study. - Has consent of parent or guardian. Exclusion Criteria Your child will not be eligible for this study if he/she: - Has ever taken NFV. - Has a history of opportunistic (AIDS-related) infection. - Has any disease or illness that would prevent him/her from completing the study, including cancer. - Has taken certain medications, including protease inhibitors at study entry. - Is receiving an HIV vaccine at study entry. - Is pregnant.
Total Enrollment: 36
Location and Contact Information:
St Lukes Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Bronx Lebanon Hosp Ctr / Dept of Pediatrics
Bronx, New York, 10457
United States
North Shore Univ Hosp / Division of Immunology
Great Neck, New York, 11021
United States
Duke Univ Med Ctr / Duke South Hosp
Durham, North Carolina, 27710
United States
Tulane Univ Med Ctr / Dept of Pediatrics
New Orleans, Louisiana, 70112
United States
Med Univ of South Carolina
Charleston, South Carolina, 29425
United States
All Children's Hosp
St. Petersburg, Florida, 33731
United States
Additional Information:
Study ID Numbers: 232H; GS-97-418
Study Start Date:
Record last reviewed: November 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002219
Other Hiv Infections Studies:
1. Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects with Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315
2. Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine
3. A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients with AIDS
4. A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults
5. The Safety of Nevirapine When Given to Breast-Feeding Babies from Birth to Age 6 Months
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
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