PREPARE (A5361s) Substudy of REPRIEVE (A5332)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 1/9/2019 |
| Start Date: | February 28, 2017 |
| End Date: | February 28, 2022 |
Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE)
Aging with HIV may be related to an earlier development of frailty (weakness) or disability,
including difficulties in tests of strength or walking speed. Few treatments have been shown
to prevent or slow these impairments in people with or without HIV. Some studies have
suggested that the class of drugs called statins (for example, pitavastatin) might be helpful
in slowing frailty or disability. This might happen by decreasing fat within the muscle or by
decreasing inflammation markers (substances in the blood that determine how the body reacts
to infection or irritation) in the blood. Other studies have shown that statins increase the
risk of muscle aches and pains. This substudy is being done to determine the impact of the
drug pitavastatin on muscle.
including difficulties in tests of strength or walking speed. Few treatments have been shown
to prevent or slow these impairments in people with or without HIV. Some studies have
suggested that the class of drugs called statins (for example, pitavastatin) might be helpful
in slowing frailty or disability. This might happen by decreasing fat within the muscle or by
decreasing inflammation markers (substances in the blood that determine how the body reacts
to infection or irritation) in the blood. Other studies have shown that statins increase the
risk of muscle aches and pains. This substudy is being done to determine the impact of the
drug pitavastatin on muscle.
A5361s is a prospective study to determine the effects of pitavastatin on physical function.
The study will enroll participants enrolled in both REPRIEVE (A5332) and its mechanistic
sub-study A5333s or in REPRIEVE (A5332) alone and follow them for 48 months after entry to
REPRIEVE (A5332). Treatment groups (pitavastatin vs placebo) will be defined according to
randomization in REPRIEVE (A5332). No intervention will be provided in this sub-study.
Study visits are scheduled at PREPARE (A5361s) entry and at months 12, 24, 36 and 48 after
REPRIEVE (A5332) entry. Each study visit will include evaluation of physical function,
frailty and self-reported physical activity and sedentary time. In addition, demographic and
clinical data, laboratory specimens and CT scans collected as part of the main study REPRIEVE
(A5332) or its mechanistic sub-study A5333s will be used.
The study will enroll participants enrolled in both REPRIEVE (A5332) and its mechanistic
sub-study A5333s or in REPRIEVE (A5332) alone and follow them for 48 months after entry to
REPRIEVE (A5332). Treatment groups (pitavastatin vs placebo) will be defined according to
randomization in REPRIEVE (A5332). No intervention will be provided in this sub-study.
Study visits are scheduled at PREPARE (A5361s) entry and at months 12, 24, 36 and 48 after
REPRIEVE (A5332) entry. Each study visit will include evaluation of physical function,
frailty and self-reported physical activity and sedentary time. In addition, demographic and
clinical data, laboratory specimens and CT scans collected as part of the main study REPRIEVE
(A5332) or its mechanistic sub-study A5333s will be used.
Inclusion Criteria:
- Ambulatory participants enrolled in both REPRIEVE (A5332) and its Mechanistic Substudy
(A5333s) or ambulatory participants who are newly enrolling into REPRIEVE (A5332) at
A5333s ACTG sites.
Exclusion Criteria:
- Inability to ambulate independently (use of a cane or a walker is permitted) or rise
from a chair without assistance.
We found this trial at
33
sites
Boston, Massachusetts 02115
Principal Investigator: Paul E. Sax, MD
Phone: 617-732-5635
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Atlanta, Georgia 30308
Principal Investigator: Carlos del Rio, MD
Phone: 404-616-6313
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Aurora, Colorado 80045
Principal Investigator: Thomas B Campbell, MD
Phone: 303-724-0712
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Baltimore, Maryland 21205
Principal Investigator: Yukari C Manabe, MD
Phone: 410-955-8571
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Birmingham, Alabama 35294
Principal Investigator: Edgar Overton, MD
Phone: 205-996-2373
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Boston, Massachusetts 02114
Principal Investigator: Rajesh Gandhi, MD
Phone: 617-724-0072
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Chapel Hill, North Carolina 27514
Principal Investigator: David Wohl, MD
Phone: 919-966-6713
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Chicago, Illinois 60611
Principal Investigator: Babafemi Taiwo, MBBS, MD
Phone: 312-695-5012
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Chicago, Illinois 60612
Principal Investigator: Beverly E Sha, MD
Phone: 312-942-2050
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Cincinnati, Ohio 45267
Principal Investigator: Carl Fichtenbaum, MD
Phone: 513-584-6383
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Cleveland, Ohio 44106
Principal Investigator: Benigno Rodriguez, MD
Phone: 216-844-2546
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Columbus, Ohio 43210
Principal Investigator: Susan Koletar, MD
Phone: 614-293-5856
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Dallas, Texas 75208
Principal Investigator: Roger Bedimo, MD, MS
Phone: 972-807-7370
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Greensboro, North Carolina 27401
Principal Investigator: Cornelius Van Dam, MD
Phone: 336-832-3262
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Houston, Texas 77030
Principal Investigator: Roberto C. Arduino, MD
Phone: 713-500-6718
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Los Angeles, California 90035
Principal Investigator: Raphael Landovitz, MD
Phone: 310-206-6414
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Los Angeles, California 90033
Principal Investigator: Fred Sattler, MD
Phone: 323-343-8283
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Miami, Florida 33139
Principal Investigator: Margaret A. Fischl, MD
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Nashville, Tennessee 37204
Principal Investigator: David Haas, MD
Phone: 615-936-8516
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New York, New York 10010
Principal Investigator: Timothy Wilkin, MD, MPH
Phone: 212-746-4177
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New York, New York 10011
Principal Investigator: Marshall J. Glesby, MD
Phone: 212-746-4393
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New York, New York 10032
Principal Investigator: Magdalena Sobieszczyk, MD, MPH
Phone: 212-305-3178
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Newark, New Jersey 07103
Principal Investigator: Shobha Swaminathan, MD
Phone: 973-973-3811
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Philadelphia, Pennsylvania 19104
Principal Investigator: Pablo Tebas, MD
Phone: 215-349-8092
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Sharon Riddler, MD, MPH
Phone: 412-383-1675
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Providence, Rhode Island 02906
Principal Investigator: Karen T. Tashima, MD
Phone: 401-793-4396
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Rochester, New York 14642
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Saint Louis, Missouri 63110
Principal Investigator: David Clifford, MD
Phone: 1-314-747-1098
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San Diego, California 92103
Principal Investigator: Constance A. Benson, MD
Phone: 619-543-3094
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San Francisco, California 94110
Principal Investigator: Diane V. Havlir, MD
Phone: 415-476-4082
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San Juan, 00935
Principal Investigator: Jorge L Santana-Bagur, MD
Phone: 1-787-767-9192
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Seattle, Washington 98104
Principal Investigator: Ann C Collier, MD
Phone: 206-744-8886
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Torrance, California 90502
Principal Investigator: Eric S. Daar, MD
Phone: 310-222-3848
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