Trial Outcomes & Findings for Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure (NCT NCT00735072)
NCT ID: NCT00735072
Last Updated: 2020-08-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2020-08-17
Participant Flow
Subjects were recruited from the HIV clinics at San Francisco General Hospital, Stanford University, Case Western Reserve University, and Rush University/CORE Center between September, 2008, and December, 2009.
All 45 enrolled patients were assigned to study intervention. We over-enrolled by 3 subjects given 2 premature treatment discontinuations and one subject with unavailable baseline peripheral blood mononuclear cell (PBMC) samples available for analysis.
Participant milestones
| Measure |
Maraviroc
Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
Placebo
Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Maraviroc
Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
Placebo
Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
|---|---|---|
|
Overall Study
interrupted study med during ARV change
|
1
|
0
|
|
Overall Study
Subject interrupted ARVs (non-adherence)
|
0
|
1
|
Baseline Characteristics
Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure
Baseline characteristics by cohort
| Measure |
Maraviroc
n=23 Participants
Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
Placebo
n=22 Participants
Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
44 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 8 • n=39 Participants
|
50 years
STANDARD_DEVIATION 10 • n=41 Participants
|
50 years
STANDARD_DEVIATION 9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=39 Participants
|
22 participants
n=41 Participants
|
45 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Outcome measures
| Measure |
Maraviroc
n=23 Participants
Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
Placebo
n=22 Participants
Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
|---|---|---|
|
Week 24 Change in Percentage of CD8+ T Cells That Co-express CD38 and HLA DR (Week 24 %CD38+HLA-DR+ CD8+ T Cells Minus Baseline %CD38+HLA-DR+ CD8+ T Cells)
|
2.2 %CD38+ HLA-DR+ CD8+ T cells
Interval -0.6 to 4.1
|
-0.7 %CD38+ HLA-DR+ CD8+ T cells
Interval -3.5 to 0.6
|
SECONDARY outcome
Timeframe: Baseline and Week 24Outcome measures
| Measure |
Maraviroc
n=22 Participants
Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
Placebo
n=21 Participants
Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
|---|---|---|
|
Change in CD4+ T Cell Count
|
17 cells/mm^3 over 24 weeks
Interval 7.0 to 28.0
|
17 cells/mm^3 over 24 weeks
Interval 7.0 to 27.0
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Data available only on the 35 participants with at least 7 mL of plasma available as reported here.
Outcome measures
| Measure |
Maraviroc
n=18 Participants
Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
Placebo
n=17 Participants
Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
|---|---|---|
|
Change in Ultra-sensitive Plasma HIV RNA Level (Single Copy/ml Assay)
|
-52 percent change from baseline
Interval -68.0 to -22.0
|
-48 percent change from baseline
Interval -72.0 to -4.0
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: These data were collected from participants enrolled at the UCSF site only, as reported here.
Outcome measures
| Measure |
Maraviroc
n=10 Participants
Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
Placebo
n=9 Participants
Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
|---|---|---|
|
Change in Brachial Artery Flow-mediated Dilatation (UCSF Site Only)
|
1.0 percent change from baseline
Interval -0.5 to 2.5
|
0.3 percent change from baseline
Interval -1.1 to 1.8
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: These data were collected from participants enrolled at the UCSF site only, as reported here.
Outcome measures
| Measure |
Maraviroc
n=6 Participants
Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
Placebo
n=6 Participants
Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
|---|---|---|
|
Change in Gut-associated Lymphoid Tissue HIV RNA Level (UCSF Site Only)
|
-11 percent change from baseline
Interval -26.0 to 23.0
|
-3 percent change from baseline
Interval -43.0 to 91.0
|
Adverse Events
Maraviroc
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Maraviroc
n=23 participants at risk
Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
Placebo
n=22 participants at risk
Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
|
|---|---|---|
|
Hepatobiliary disorders
Indirect Hyperbilirubinemia (on atazanavir-based ART)
|
8.7%
2/23 • 36 weeks
|
4.5%
1/22 • 36 weeks
|
|
Infections and infestations
Prolonged Fever
|
4.3%
1/23 • 36 weeks
|
0.00%
0/22 • 36 weeks
|
|
Metabolism and nutrition disorders
Triglyceride Elevation
|
4.3%
1/23 • 36 weeks
|
0.00%
0/22 • 36 weeks
|
|
Hepatobiliary disorders
HBV flare, transaminitis
|
0.00%
0/23 • 36 weeks
|
4.5%
1/22 • 36 weeks
|
Additional Information
Peter W. Hunt, MD
University of California, San Francisco
Phone: (415) 476-4082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place