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Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination with 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination with 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination with 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors Clinical research trials and Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination with 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors medical trials happen in hundreds of localities throughout 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 typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination with 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors. Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination with 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination with 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors clinical trial. Participants frequently obtain the most expert healthcare available for their Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination with 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.

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Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination with 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors



Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination with 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors

For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to see if it is safe and effective to add a new protease inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse transcriptase inhibitors (NRTIs).
Details: In this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to receive 2 NRTIs plus either 141W94 or placebo. Enrollment of patients is sequential: patients 13 to 18 years of age are enrolled first, followed by children < 13 when the appropriate pediatric dose has been determined. Patients who are unable to swallow capsules will be accrued when a liquid formulation becomes available.
Eligibility:
Study Type:
  Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 6 Months/18 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Your child may be eligible for this study if he/she: - Is 6 months - 18 years of age. - Is HIV-positive. - Has a viral load (level of HIV in the body) greater than 10,000 copies/ml. - Is able to take medications by mouth. - Has consent of parent or legal guardian if under 18. - Has a negative pregnancy test within 7 days of study entry. - Agrees to practice abstinence or use effective methods of birth control for 1 month before and throughout the study. Exclusion Criteria Your child will not be eligible for this study if he/she: - Has a serious illness, including any life-threatening infection or other chronic serious medical condition. - Has an opportunistic (AIDS-related) infection or a serious bacterial infection. - Is allergic to NRTIs. - Is breast-feeding. - Is unlikely to complete the study. - Has received certain medications. - Has received radiation therapy within the past 4 months, or will need to receive it during the study.
Total Enrollment: 210

Location and Contact Information:

Saint Jude Children's Hosp / Dept of Infect Diseases
Memphis,  Tennessee,  38105
United States
 

Children's Diagnostic Treatment Ctr
Ft. Lauderdale,  Florida,  33301
United States
 


Additional Information:
Study ID Numbers:
  264C;  PROA3004
Study Start Date: 
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002193

Other Hiv Infections Studies:
1. Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Antiretroviral Treatment in HIV-Infected Patients with CD4 T-Lymphocyte Count Greater Than 500 Cells/mm3 Who Have Received Antiretroviral Treatment

2. Assessment of Attentional Functioning in Children with HIV-1 Infection

3. A Study of Delavirdine Used Together with Other Anti-HIV Drugs in HIV-Infected Patients

4. Tuberculosis Prevention for HIV Infected Adults

5. A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure

Related Studies:

Other HIV Infections Clinical Trials
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