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A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy with Combination Ritonavir, Nevirapine and Stavudine 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 A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy with Combination Ritonavir, Nevirapine and Stavudine conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy with Combination Ritonavir, Nevirapine and Stavudine Clinical research trials and A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy with Combination Ritonavir, Nevirapine and Stavudine 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 A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy with Combination Ritonavir, Nevirapine and Stavudine. A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy with Combination Ritonavir, Nevirapine and Stavudine 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 A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy with Combination Ritonavir, Nevirapine and Stavudine clinical trial. Participants frequently get the best healthcare available for their A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy with Combination Ritonavir, Nevirapine and Stavudine 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 > "A" Clinical Trials Conditions > A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy with Combination Ritonavir, Nevirapine and Stavudine  A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy with Combination Ritonavir, Nevirapine and Stavudine
A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy with Combination Ritonavir, Nevirapine and Stavudine
For Condition: HIV Infection
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a pilot study to evaluate the ability of highly active antiretroviral therapy administered to children with HIV-1 infection to effect immunoreconstitution in children with HIV-1 infection. In addition, this study will determine the safety of combination therapy with ritonavir, nevirapine and stavudine (d4T) as well as the anti-HIV activity of combination therapy with ritonavir, nevirapine and stavudine. A total of 25 HIV-1 infected children will be studied, including both moderately and severely immunocompromised individuals. The children will be treated with ritonavir, nevirapine and stavudine or with predefined drug substitutions in the case of intolerance. Immunoreconstitution, defined as the repopulation of naive T cells, will be studied by determining the presence and extent of production of new naive (thymic derived) CD4+ T cells and their T cell receptor repertoire. Drug pharmacokinetic profiles in this regimen will be examined.
Details: This is a pilot study to evaluate the ability of highly active antiretroviral therapy administered to children with HIV-1 infection to effect immunoreconstitution in children with HIV-1 infection. In addition, this study will determine the safety of combination therapy with ritonavir, nevirapine and stavudine (d4T) as well as the anti-HIV activity of combination therapy with ritonavir, nevirapine and stavudine. A total of 25 HIV-1 infected children will be studied, including both moderately and severely immunocompromised individuals. The children will be treated with ritonavir, nevirapine and stavudine or with predefined drug substitutions in the case of intolerance. Immunoreconstitution, defined as the repopulation of naive T cells, will be studied by determining the presence and extent of production of new naive (thymic derived) CD4+ T cells and their T cell receptor repertoire. Drug pharmacokinetic profiles in this regimen will be examined.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Children between ages of 4 years and 18 years. Diagnosis of HIV-1 infection as defined by the Centers for Disease Control (CDC) Definition. Availability of a parent or guardian to provide Informed Consent. Child is not critically ill or clinically unstable. No CDC categories N1 and A1 (1994 revised classification for HIV infection in children less than 13 years of age) and the CDC 1993 revised HIV classification and expanded AIDS surveillance definition for adolescents and adults. Non-presence of an active opportunistic infection requiring acute intervention at the time of entry (e.g. CMV, aspergillosis, cryptococcosis, Candida, etc.). Patients receiving treatment for an infection that requires prolonged treatment must have been stable on therapy for at least 30 days prior to study entry. No administration of chemotherapeutic agents, investigational agents or use of immunomodulating agents such as IVIG, corticosteroids, interferons, pentoxifylline, G-CSF/GM-CSF, erythropoeitin, growth hormone and other growth factors within one month of enrollment. None of the following laboratory abnormalities within 2 weeks of study entry: Total WBC count less than 1500/mm(3) or an absolute neutrophil count less than 750/mm(3); Hemoglobin less than 8.0 g/dl; Platelet count less than 75,000/mm(3); Creatinine greater than 2.0 x normal; Creatinine clearance less than or equal to 50 mL/min/m(2); Total bilirubin greater than 2 x normal; SGOT/SGPT greater than 5 x normal; Serum amylase pancreatic isoenzyme greater than 90 U/L (2 x upper limit of normal for adult). Serum amylase pancreatic isoenzyme should be obtained only if total serum amylase is greater than 180 U/L. No history of clinical pancreatitis and/or elevation in serum amylase pancreatic isoenzyme of greater than 180 U/L. No history of peripheral neuropathy of Grade II or greater severity. No previous treatment with ritonavir, indinavir, nelfinavir, nevirapine or stavudine. Patients may have received treatment with ritonavir, indinavir, nelfinavir for less than 4 weeks. Ability to swallow tablets. No child for whom the volume of research blood required for study evaluation exceeds the maximum volume of research blood allowable (3 ml/kg in a single blood withdrawal and 7 ml/kg in a 6-week period). This would be applicable to a child less than 16.5 kg. No patients who refuse or cannot have leukapheresis done. Sexually active post-menarchal females must be willing to use a barrier method of contraception or be willing to remain sexually abstinent.
Total Enrollment: 25
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980041; 98-C-0041
Study Start Date: January 8, 1998
Record last reviewed: November 13, 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001688
Other Hiv Infection Studies:
1. Screening HIV-Infected Patients for Vaccine Studies
2. Home Treatment of HIV-Infected Patients with Interleukin-2 with or without a Tumor Necrosis Factor Antagonist
3. Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV
4. Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination with Synthetic HIV Envelope Peptides in Patients with Early Human Immunodeficiency Virus Infection
5. Specimen Collections from Patients with HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
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A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy with Combination Ritonavir, Nevirapine and Stavudine
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