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A Pilot Project of Virologic, Pharmacologic and Immunologic Correlates of Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution Following Maraviroc Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00870363
First received: March 25, 2009
Last updated: May 24, 2017
Last verified: May 2017
Results First Received: January 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor)
Drug: maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor)
Drug: efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Maraviroc in Combination With 2 NRTIs

maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician

maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician

Maraviroc PLUS Raltegravir in Combination With 2 NRTIs

maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician

maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician

Efavirenz or Other NNRTI With 2 NRTIs

efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician

efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician

HIV Negative Controls Not on ART HIV-negative

Participant Flow:   Overall Study
    Maraviroc in Combination With 2 NRTIs   Maraviroc PLUS Raltegravir in Combination With 2 NRTIs   Efavirenz or Other NNRTI With 2 NRTIs   HIV Negative Controls Not on ART
STARTED   10   11   11   12 
COMPLETED   10   8   8   12 
NOT COMPLETED   0   3   3   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Maraviroc in Combination With 2 NRTIs

maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician

maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician

Maraviroc PLUS Raltegravir in Combination With 2 NRTIs

maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician

maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician

Efavirenz or Other NNRTI With 2 NRTIs

efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician

efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician

HIV Negative Controls Not on ART HIV-negative
Total Total of all reporting groups

Baseline Measures
   Maraviroc in Combination With 2 NRTIs   Maraviroc PLUS Raltegravir in Combination With 2 NRTIs   Efavirenz or Other NNRTI With 2 NRTIs   HIV Negative Controls Not on ART   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   8   8   12   38 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 38 
 (25 to 43) 
 35 
 (27 to 40) 
 37 
 (25 to 46) 
 35 
 (29 to 42) 
 37 
 (25 to 42) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      3  30.0%      1  12.5%      0   0.0%      5  41.7%      9  23.7% 
Male      7  70.0%      7  87.5%      8 100.0%      7  58.3%      29  76.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1  12.5%      1  12.5%      1   8.3%      3   7.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      1  12.5%      1   8.3%      2   5.3% 
Black or African American      5  50.0%      4  50.0%      1  12.5%      1   8.3%      11  28.9% 
White      5  50.0%      3  37.5%      5  62.5%      9  75.0%      22  57.9% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   10   8   8   12   38 
CD4 T-Cell count [1] 
[Units: CELLS/MM^3]
Median (Inter-Quartile Range)
 441 
 (369 to 511) 
 453 
 (334 to 713) 
 322 
 (233 to 536) 
 NA [1]   436 
 (283 to 572) 
[1] not measured in the negative control cohort


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in the Density of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Following Antiretroviral Therapy Regimen   [ Time Frame: Baseline and nine months for 3 treatment cohorts and Baseline for the control group, which was only assessed at one time point ]

2.  Secondary:   Trough Plasma and Tissue Drug Levels in Volunteers at the Time of the Upper Endoscopy   [ Time Frame: nine months ]

3.  Secondary:   Change in HIV DNA Per 10^6 Cells in Duodenal Tissue Versus PBMC by Drug Regimen Received   [ Time Frame: Baseline and nine months ]

4.  Secondary:   Change in GALT CD4+ and CD8+ T-cell Subpopulations (naïve and Memory Subsets)   [ Time Frame: nine months ]

5.  Secondary:   Lymphocyte Immune Function and Activation at Two Time Points Approximately Nine Months Apart in GALT; and Four Timepoints (Month 0, 3, 6, and 9) in Peripheral Blood   [ Time Frame: nine months ]

6.  Secondary:   Changes in CD4+ T-cell Numbers by Treatment Regimen   [ Time Frame: Baseline and nine months ]

7.  Secondary:   Immune Reconstitution With Respect to Absolute Numbers of CD4+ T-cells, the Relative Proportion of T-cell Subpopulations in the Tissue, and Immune Activation to a Cohort of Normal Controls   [ Time Frame: nine months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David M Asmuth
Organization: University of California Davis Medical Center
phone: (916) 734-8695
e-mail: dasmuth@ucdavis.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00870363     History of Changes
Other Study ID Numbers: 200816535
Study First Received: March 25, 2009
Results First Received: January 12, 2017
Last Updated: May 24, 2017