Study of Anti-HIV Therapy Intensification
Immunologic Consequences of Antiretroviral Therapy Intensification in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315/375
8 other identifiers
interventional
22
1 country
3
Brief Summary
The purpose of this study is to see how the body's immune system changes after replacing and adding new anti-HIV drugs to a patient's current anti-HIV therapy. This study will also see whether adding drugs is safe. Patients who take part in A5136 are also eligible to take part in 2 substudies. The purpose of substudy A5140s is to see how many latently infected cells (cells in which the HIV virus survives) are in the lymph node (small, rounded structures that make disease-fighting cells). Substudy A5155s will be performed to see how many latently infected cells are in the blood before and after replacing and adding anti-HIV drugs. ACTG A5136 is a follow-up study to ACTG 315 and ACTG 375, which were designed to examine the effects of highly active antiretroviral therapy (HAART) in certain HIV-infected patients. Many HIV-infected patients have undergone long-term anti-HIV therapy and have had the virus suppressed. However, most of these patients still have problems with their immune systems. The reason for these problems is unknown. This study may help researchers understand what causes immune system problems in people who have low levels of HIV in their blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2002
CompletedFirst Posted
Study publicly available on registry
April 23, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedMay 18, 2012
May 1, 2012
April 22, 2002
May 17, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Have completed ACTG 375 within 2 weeks of finishing Week 230.
- Have a viral load less than 400 copies/ml within 90 days prior to study entry.
- Agree not to become pregnant or to impregnate during the study. The female patient/male partner must use acceptable methods of contraception while receiving study drugs and for 1 month after stopping the drugs. Women and men who cannot have children are eligible without requiring the use of contraception, but they must provide acceptable documentation of menopause, sterilization, or lack of sperm cells.
You may not qualify if:
- Patients may not be eligible for this study if they:
- Need to use certain drugs within 30 days of study entry.
- Have taken any immunomodulatory therapies within 30 days prior to study entry unless approved by the protocol chairs.
- Have a history of serious kidney problems.
- Are allergic or sensitive to the study drugs.
- Are pregnant or breast-feeding.
- Have an alcohol or drug dependency that, in the opinion of the investigator, would interfere with the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Colorado Hospital CRS
Aurora, Colorado, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
Case CRS
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kimberly Smith
- STUDY CHAIR
Hernan Valdez
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2002
First Posted
April 23, 2002
Study Completion
June 1, 2006
Last Updated
May 18, 2012
Record last verified: 2012-05