Consent for using stored patient samples for future testing
Plan for Obtaining Informed Consent to Use Stored Human Biological Materials (HBM) for Currently Unspecified Analyses
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · NCT00031408
This study is asking patients if they agree to let researchers use their leftover blood and tissue samples for future HIV research to help improve understanding and treatment of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30000 (estimated) |
| Sex | All |
| Sponsor | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (network) |
| Locations | 63 sites (Los Angeles, California and 62 other locations) |
| Trial ID | NCT00031408 on ClinicalTrials.gov |
What this trial studies
This study aims to obtain informed consent from patients to use their stored human biological materials, such as blood and tissues, for future research, including genetic testing related to HIV. Participants will be asked to consent to the use of leftover samples from previous clinical trials and to provide a blood sample for DNA archiving. The goal is to enhance the understanding of HIV disease and improve its management by allowing researchers access to archived samples for unspecified analyses. Participation does not affect involvement in other clinical trials.
Who should consider this trial
Good fit: Ideal candidates are individuals currently participating in or who have previously participated in an AACTG clinical trial.
Not a fit: Patients who do not wish to consent to the use of their biological materials for future testing will not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved understanding and management of HIV infections through future research utilizing stored biological materials.
How similar studies have performed: Other studies utilizing stored biological materials for research have shown success, indicating that this approach is supported by prior findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parent or guardian willing to give informed consent, if applicable * Either currently participating in or have ever participated in an AACTG clinical trial
Where this trial is running
Los Angeles, California and 62 other locations
- Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States (RECRUITING)
- Charles Drew Medical Center — Los Angeles, California, United States (RECRUITING)
- UCLA CARE Ctr — Los Angeles, California, United States (RECRUITING)
- Univ of California, San Diego — San Diego, California, United States (RECRUITING)
- Univ of California San Francisco — San Francisco, California, United States (RECRUITING)
- San Mateo AIDS Program / Stanford Univ — Stanford, California, United States (RECRUITING)
- Stanford Univ Med Ctr — Stanford, California, United States (RECRUITING)
- Willow Clinic / Stanford Univ — Stanford, California, United States (RECRUITING)
- Harbor General/UCLA — Torrance, California, United States (RECRUITING)
- Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States (RECRUITING)
- Georgetown Univ Med Ctr — Washington, District of Columbia, United States (RECRUITING)
- Univ of Miami School of Medicine — Miami, Florida, United States (RECRUITING)
- Emory Univ — Atlanta, Georgia, United States (RECRUITING)
- Northwestern Univ Med School — Chicago, Illinois, United States (RECRUITING)
- Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States (RECRUITING)
- The CORE Ctr — Chicago, Illinois, United States (RECRUITING)
- Indiana Univ Hosp — Indianapolis, Indiana, United States (RECRUITING)
- Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States (RECRUITING)
- Wishard Hosp — Indianapolis, Indiana, United States (RECRUITING)
- Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS (1504) — Iowa City, Iowa, United States (RECRUITING)
- Univ of Maryland, Institute of Human Virology — Baltimore, Maryland, United States (RECRUITING)
- Johns Hopkins Hosp — Baltimore, Maryland, United States (RECRUITING)
- Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States (RECRUITING)
- Boston Med Ctr — Boston, Massachusetts, United States (RECRUITING)
- Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States (RECRUITING)
- Brigham and Women's Hosp — Boston, Massachusetts, United States (RECRUITING)
- Univ of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
- Washington Univ / St Louis Connect Care — Saint Louis, Missouri, United States (RECRUITING)
- Washington Univ School of Medicine — St Louis, Missouri, United States (RECRUITING)
- Specialty Care Center CRS 1505 — Omaha, Nebraska, United States (RECRUITING)
- New Jersey Medical School- Adult CRS (31477) — Newark,, New Jersey, United States (RECRUITING)
- SUNY / Erie County Med Ctr at Buffalo — Buffalo, New York, United States (RECRUITING)
- Beth Israel Med Ctr — New York, New York, United States (RECRUITING)
- Cornell Clinical Trials Unit - Chelsea Clinic — New York, New York, United States (RECRUITING)
- Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States (RECRUITING)
- Cornell Univ Med Ctr — New York, New York, United States (RECRUITING)
- The Cornell Clinical Trials Unit — New York, New York, United States (RECRUITING)
- Mount Sinai Med Ctr — New York, New York, United States (RECRUITING)
- Columbia Presbyterian Med Ctr — New York, New York, United States (RECRUITING)
- Community Health Network Inc — Rochester, New York, United States (RECRUITING)
- St Mary's Hosp (Univ of Rochester/Infectious Diseases) — Rochester, New York, United States (RECRUITING)
- Univ of Rochester Medical Center — Rochester, New York, United States (RECRUITING)
- Wake County Health and Human Services CRS (30076) — Chapel Hill, North Carolina, United States (RECRUITING)
- Univ of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)
- Duke Univ Med Ctr — Durham, North Carolina, United States (RECRUITING)
- Greensboro CRS — Greensboro, North Carolina, United States (RECRUITING)
- Univ of Cincinnati — Cincinnati, Ohio, United States (RECRUITING)
- Cleveland Clinic (A2508) — Cleveland, Ohio, United States (RECRUITING)
- Case Western Reserve Univ — Cleveland, Ohio, United States (RECRUITING)
- Ohio State Univ Hosp Clinic — Columbus, Ohio, United States (RECRUITING)
+13 more sites — see ClinicalTrials.gov for the full list.
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV Infections, Specimen Handling, Blood, Informed Consent, Genetic Screening