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Growth Hormone Treatment of Children with HIV-Associated Growth Failure Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Growth Hormone Treatment of Children with HIV-Associated Growth Failure conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Growth Hormone Treatment of Children with HIV-Associated Growth Failure Clinical research trials and Growth Hormone Treatment of Children with HIV-Associated Growth Failure medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Growth Hormone Treatment of Children with HIV-Associated Growth Failure. Growth Hormone Treatment of Children with HIV-Associated Growth Failure Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Growth Hormone Treatment of Children with HIV-Associated Growth Failure clinical trial. Participants oftentimes recieve the finest healthcare available for their Growth Hormone Treatment of Children with HIV-Associated Growth Failure condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Growth Hormone Treatment of Children with HIV-Associated Growth Failure  Growth Hormone Treatment of Children with HIV-Associated Growth Failure
Growth Hormone Treatment of Children with HIV-Associated Growth Failure
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 determine the effectiveness of recombinant human growth hormone (r-hGH) on growth in HIV-infected children. Studies have shown that HIV-infected children do not grow at a normal rate and are shorter than HIV-uninfected children who are the same age. Growth hormone has been used for many years to treat children with growth hormone deficiency and has been safe and effective in helping them to grow normally. The growth hormone to be used in this study, r-hGH, is an investigational hormone (not yet approved by the Food and Drug Administration [FDA]) made in the laboratory. It has helped HIV-positive adults gain weight and improve their physical performance. This study has been changed to include a needle-free device for drug delivery which will improve patient comfort and acceptability. Patients will no longer receive growth hormone through traditional needles but through a needle-free device.
Details: Wasting, or loss of lean tissue, is a serious consequence of AIDS. Body composition findings in HIV-infected children are similar to those of HIV-uninfected children with classic growth hormone deficiency. Evidence suggests that therapeutic administration of growth hormone (GH) can induce anabolic effects, reverse pathologic catabolism, and perhaps even improve immune function. As survival to adolescence and beyond improves with modern therapy in children with HIV infection, it will become increasingly important to address the problems of stunting and short stature in this population. [AS PER AMENDMENT 09/04/01: Recent evidence suggests that needle-free delivery is preferred by young children below the age of ten years. Given the advantages of a needle-free delivery system for the administration of growth hormone, most significantly the reduction of risk for HIV contaminated needle-stick injuries to care providers and other household members, it has been decided to use this method of study drug delivery for all study participants.] Children are assigned randomly to 1 of the following treatment groups: Group 1: Children receive a single dose of r-hGH once a day. Group 2: Children receive half the dose of r-hGH that Group 1 receives, once a day. Group 3a: Children receive no r-hGH for the first 24 weeks [AS PER AMENDMENT 01/03/01: 48 weeks] of the study. After Week 24 [AS PER AMENDMENT 01/03/01: Week 48], they receive the same dose as that of Group 1. Group 3b: Children receive no r-hGH for the first 24 weeks [AS PER AMENDMENT 01/03/01: 48 weeks] of the study. After Week 24 [AS PER AMENDMENT 01/03/01: Week 48], they receive the same dose as that of Group 2. Subcutaneous injections are administered [AS PER AMENDMENT 09/04/01: using a needle-free device], daily for 96 weeks in Groups 1 and 2; after 24 weeks [AS PER AMENDMENT 01/03/01: 48 weeks] on study, the treatment-delayed control group (Group 3) receives injections for 72 weeks [AS PER AMENDMENT 01/03/01: 48 weeks]. The first injection is at the clinic and parents/guardians are trained how to prepare and administer the injections. Children are closely monitored for toxicity, with dosing adjustments if needed. Evaluations and laboratory tests are done at clinic visits every 4 weeks to determine growth indicators, body chemistries, CD4 cell counts, HIV-1 RNA PCR, and anti-hGH antibodies and for routine hematology testing, dietary intake assessment, and MRI scans. [AS PER AMENDMENT 01/03/01: MRI scans are no longer performed.]
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 4 Years/13 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Children may be eligible for this study if they: - Are 4 to 12 years of age for girls, and 4 to 13 years of age for boys (consent of parent/guardian is required). - Are HIV-positive. - Are not growing normally. - Have a normal intake of food each day. - Are able to walk. - Have been on stable anti-HIV therapy for at least 24 weeks before study entry and will continue therapy for the entire duration of the study with no anticipated change in therapy for the first 48 weeks of the study. (These therapy requirements reflect a change.) - Are willing and able to follow study requirements. Exclusion Criteria Children may not be eligible for this study if they: - Had steady fever of 101 degrees F or higher during the 2 weeks before study entry. - Have a serious infection requiring medications within 30 days prior to study entry. - Are being fed through a vein. - Have severe diarrhea, intestinal bleeding or blockage, or are unable to absorb food. - Have cancer. - Have taken medications that may interfere with the study drug or have had radiation. - Have diabetes or a history of sugar intolerance. - Have carpal tunnel syndrome (unless it has been surgically repaired). - Have heart or kidney problems, or serious swelling of any kind. - Have any condition other than HIV infections that may have affected growth or that makes it difficult to measure height. - Have any known allergies to the study drug.
Total Enrollment: 102
Location and Contact Information:
Overall Study Official:
HarlandWinter, Study Chair,
Univ of California, San Diego
San Diego, California, 92103
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Phoenix Childrens Hosp
Phoenix, Arizona, 85006
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Additional Information:
Study ID Numbers: ACTG P1011; PACTG P1011
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006143
Other Hiv Infections Studies:
1. Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis
2. Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups
3. Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
4. A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection
5. An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients with Progressive HIV Disease
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
Growth Hormone Treatment of Children with HIV-Associated Growth Failure
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