N/A
N=25
Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy
HIV Infections · AIDS
Bottom Line
View on ClinicalTrials.gov: NCT00661960 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over Time. — 55.3; 11.7; 9.9 % CD3/CD4 T-cells in GALT tissue
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- raltegravir (Drug); efavirenz (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over Time. |
55.3; 11.7; 9.9 | — |
Summary
This research is being done to study how the immune system in the small intestine improves after taking antiretroviral (anti-HIV) medications. The main purpose is to measure the increase in the numbers of immune cells in the intestine to see if one type of HIV medication gives different results than other types of HIV medications.
Eligibility Criteria
Inclusion Criteria
- willing to sign consent form
- no known GI pathology
- no anticipated antiretroviral therapy adjustments or changes
- males & females between the ages of 18 & 50 years
- no active opportunistic infections (OI) or therapy for OI within 30 days of entry
- can be on secondary prophylaxis with a history of AIDS defining illness
- per standard of care requirements, all females of child-bearing potential must agree to use barrier methods to prevent pregnancy or be abstinent from activity while on study
Exclusion Criteria
- abnormal coagulation parameters (PT > or equal to 1.2 ULN)
- thrombocytopenia (platelet count or equal to grade 1)
- aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy
Data sourced from ClinicalTrials.gov (NCT00661960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.