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Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV Clinical research trials and Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV. Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV clinical trial. Human subjects often get the best healthcare possible for their Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV  Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV
Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV
For Condition: HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: Some patients taking anti-HIV drugs as part of highly active antiretroviral therapy (HAART) do not show any HIV in the blood; however, some HIV will remain hidden in the body and, if the drugs are stopped, will return to the blood. The purpose of this study is to determine if short periods of stopping HAART increase the activity of CD8 and CD4 cells (cells of the immune system that fight infection), if repeated stopping of these drugs for longer periods of time and restarting them will increase effectiveness of HAART, and if the increased immune system activity as a result of stopping treatment leads to lower levels of HIV over time.
Details: Some HIV infected patients taking HAART have been able to achieve prolonged suppression of HIV viral load for extended periods of time. However, discontinuing HAART has consistently resulted in HIV's return to plasma. Both CD8 and CD4 cells are markedly reduced in individuals with prolonged HIV suppression; control of and response to cell-associated HIV is dependent on immune-mediated mechanisms involving these cells. It is hypothesized that a brief and low-level increase in HIV levels resulting from HAART interruption might boost HIV-specific CD8 and CD4 T-cell counts. After suppression of viral load with the reintroduction of HAART, the expanded CD8 population might be able to better control viral replication and better respond to cell-associated HIV. Future treatment interruption may lead to longer periods of undetectable viral loads. Patients are divided into 2 age cohorts, with Cohort 1 consisting of children and adolescents 4 years and older up to 21 years of age, and Cohort 2 consisting of children and adolescents 2 years and older up to 4 years of age. Patients will be assigned to one of 2 groups. Group A patients will participate in drug holiday cycles from HAART and then back to HAART; Group B is a control group that remains on continuous HAART throughout the study. Cycle 1 for Group A patients begins with 18 days of HAART and a 3-day drug holiday. At the end of the drug holiday, viral load is measured and HAART is resumed for 28 days (detectable virus cycle) if viral load is detectable after the drug holiday. If viral load remains below the level of detection, the patient begins the next drug holiday cycle. With each subsequent drug holiday cycle, time off HAART will increase by 2 days. Patients failing 4 repeated detectable virus (28-day treatment) cycles will be taken off study. Patients will be enrolled in this study for a minimum of 142 weeks. For Group A, HIV viral load and CD4 cell count are measured at the end of each drug holiday and each HAART resumption; HIV-specific CD4 and CD8 responses are measured every 3 cycles; and cell-associated HIV is assessed at entry, at 12-week intervals, and at the end of the study. For Group B, physical exams are conducted and HIV viral load and other blood work are measured every 12 weeks.
Eligibility:
Study Type: Observational, Natural History, Longitudinal, Defined Population, Prospective Study
Minimum Age/Maximum Age: 2 Years/21 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV infected - For Cohort 1, CD4 T-cell percent greater than 20 - For Cohort 2, CD4 T-cell percent greater than 25 - Viral load less than 400 copies/ml in the year prior to study entry and less than 50 copies/ml at screening - Taking anti-HIV drugs (including at least 1 protease inhibitor) and have been on anti-HIV drugs for at least 1 year prior to study entry - Have been on their current drug regimen for at least 4 months - Willing to follow study procedures - Parental or guardian consent if under 18 years old - Acceptable forms of contraception Exclusion Criteria - Taking abacavir, nevirapine, efavirenz, or delavirdine - AIDS-related or other infections needing drug treatment at study entry - Pregnant or breastfeeding - Have, or have had in the past, diseases (other than HIV infection) or other conditions that, in the doctor's opinion, would interfere with the study - Taking experimental drugs without the consent of the protocol team
Total Enrollment: 39
Location and Contact Information:
Overall Study Official:
WilliamBorkowsky, Study Chair, New York University Medical Center, Pediatric Infectious Diseases
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Patricia Yu 202-865-4578
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Kirk Bertelsen 617-355-8198
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Patricia Bryan 305-243-2154
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Caroline Nubel 718-960-1020
Harlem Hosp Ctr
New York City, New York, 10037
United States
Delia Calo 212-939-4045
St. Lukes/Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Eva Operskalski 323-226-2342
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Michell Davi 516-444-1313
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Debbie Fonken-Cloutier 773-880-3669
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Carol Salbenblatt 303-861-6751
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Kathie Contello 315-464-6331
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Kathryn Owl 832-824-2583
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Mary Hoyt 973-972-3118
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 21287
United States
Suzanne Marvin 410-955-9749
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Maria Pilar Thurin 787-765-4186
Additional Information:
Study ID Numbers: ACTG P1015; PACTG P1015
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016783
Other Hiv Infections Studies:
1. A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules
2. Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir
3. Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
4. A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
5. A Study of WF 10 IV Solution in Patients with Advanced HIV Disease
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Stopping and Restarting Anti-HIV Drugs in Children and Adolescents with Low Blood Levels of HIV
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