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A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications 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 A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications Clinical research trials and A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications 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 A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications. A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications 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 A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications clinical trial. Participants frequently obtain the most expert healthcare available for their A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications 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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Home > "A" Clinical Trials Conditions > A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications  A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications
A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: The purpose of this study is to find out if it is safe for HIV-positive children who are responding well to their anti-HIV treatment to stop taking medications that prevent AIDS-related infections (opportunistic infections) such as pneumonia and other bacterial infections. This is an observational study, meaning children will only be monitored to see if they develop any infections. Children have been receiving medications to prevent complications of HIV infection, such as Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC) disease, or other bacterial infections. It is common for HIV-positive patients with low CD4 counts to receive these preventive medications. However, these drugs can have serious side effects, they are expensive, and it is possible for bacteria resistant to the drugs to grow. For these reasons, it may be beneficial to the child to stop taking these preventive medications if he/she has been on anti-HIV (antiretroviral) therapy and has improved CD4 counts. This study will look at how many children who stop taking their medications develop opportunistic infections.
Details: Due to the strong correlation between a significant decrease in CD4 count and the frequency and magnitude of OIs such as Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC), and severe bacterial infections, CD4 count has become the major criterion for initiating antimicrobial prophylaxis for OIs. However, despite the benefits of these antimicrobial drugs, all are associated with adverse side effects, and patients with reconstituted immune systems following antiretroviral therapy may be receiving prophylaxis unnecessarily. Benefits to stopping prophylaxis include: (1) elimination of adverse effects from drugs; (2) reduction in drug costs; and (3) removal of selective pressure for the development of drug-resistant microbes. These benefits must be weighed against the disadvantages, however, such as more frequent determinations of CD4 counts to assure maintenance of immunocompetence, more frequent occurrence of serious OIs otherwise preventable with prophylaxis in patients lost to follow-up, and possible occurrence of atypical PCP because of prior exposure to anti-PCP drugs. [AS PER AMENDMENT 04/26/02: The extent of complete immune restitution has not yet been defined. An important corollary of an incomplete immune recovery is that vaccination schedules might need to be adjusted to obtain optimal responses in HIV-infected patients on highly active antiretroviral therapy (HAART). Therefore, a third dose of hepatitis A virus vaccine will be administered.] After pre-entry and entry laboratory studies, patients are followed every 8 weeks until the last patient has completed 104 weeks of study observation. Hepatitis A vaccination is administered at entry and Week 24 to measure responses to neoantigen. [AS PER AMENDMENT 04/26/02: All patients (except those co-enrolled in P1024 on or after November 1, 2001) who have received 2 doses of hepatitis A virus vaccine during the study will be offered an opportunity to enroll in Step II of P1008. Patients in Step II receive a third dose of hepatitis A vaccination at Week 104 or later. Additional blood samples are taken 8 weeks later for antibody detection and peripheral blood mononuclear cell (PBMC) cryopreservation.] All serious bacterial infections that are Grade 3 or higher and OI events are recorded and compared to historical event rates. Virologic and immunologic marker studies are done in all patients and correlated with the risk of developing serious bacterial infections or OI events. Patients are considered to have reached an endpoint if they develop PCP, 2 serious bacterial infections, other Category C OI diagnoses, or CD4% less than 15% and re-initiation of PCP prophylaxis.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 2 Years/21 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Children may be eligible for this study if they: - Are HIV-positive. - Have a CD4 percent greater than or equal to 25 percent if they are under 6 years of age, or have a CD4 percent greater than or equal to 20 percent on 2 occasions if they are between the ages of 6 and 21. - Have been receiving preventive treatment for PCP for at least 6 months and have not stopped treatment for more than 3 months before study entry. - Are willing to stop taking preventive treatment for PCP and MAC. - Have received the same continuous antiretroviral (anti-HIV) therapy for the 16 weeks before beginning the study. (Continuous therapy means missing no more than a total of 3 weeks during the 16 weeks.) - Are between the ages of 2 and 21 years (consent of parent or guardian is required if under 18). Exclusion Criteria Children will not be eligible for this study if they: - Have PCP. - Have any other active infection, such as tuberculosis or toxoplasmosis, or any other significant disease. - Are receiving chemotherapy for cancer or certain other medications.
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
WayneDankner, Study Chair,
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
Phoenix Childrens Hosp
Phoenix, Arizona, 85006
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
United States
Additional Information:
Study ID Numbers: ACTG P1008; PACTG P1008
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001078
Other Hiv Infections Studies:
1. Identifying Emergency Room Patients Who Have Recently Been Infected with HIV
2. The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients
3. A Study of HIV and Cytomegalovirus (CMV) in HIV-Infected Patients
4. Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children with Weakened Immune Systems
5. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications
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