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
Newark, New Jersey 07103
Principal Investigator: Shobha Swaminathan, MD
Phone: 973-973-3811
Click here to add this to my saved trials
Atlanta, Georgia 30308
Principal Investigator: Carlos del Rio, MD
Phone: 404-616-6313
Click here to add this to my saved trials
Aurora, Colorado 80045
Principal Investigator: Thomas B Campbell, MD
Phone: 303-724-0712
Click here to add this to my saved trials
Baltimore, Maryland 21205
Principal Investigator: Yukari C Manabe, MD
Phone: 410-955-8571
Click here to add this to my saved trials
Birmingham, Alabama 35294
Principal Investigator: Edgar Overton, MD
Phone: 205-996-2373
Click here to add this to my saved trials
Boston, Massachusetts 02114
Principal Investigator: Rajesh Gandhi, MD
Phone: 617-724-0072
Click here to add this to my saved trials
Boston, Massachusetts 02115
Principal Investigator: Paul E. Sax, MD
Phone: 617-732-5635
Click here to add this to my saved trials
Chapel Hill, North Carolina 27514
Principal Investigator: David Wohl, MD
Phone: 919-966-6713
Click here to add this to my saved trials
Chicago, Illinois 60611
Principal Investigator: Babafemi Taiwo, MBBS, MD
Phone: 312-695-5012
Click here to add this to my saved trials
Chicago, Illinois 60612
Principal Investigator: Beverly E Sha, MD
Phone: 312-942-2050
Click here to add this to my saved trials
Cincinnati, Ohio 45267
Principal Investigator: Carl Fichtenbaum, MD
Phone: 513-584-6383
Click here to add this to my saved trials
Cleveland, Ohio 44106
Principal Investigator: Benigno Rodriguez, MD
Phone: 216-844-2546
Click here to add this to my saved trials
Columbus, Ohio 43210
Principal Investigator: Susan Koletar, MD
Phone: 614-293-5856
Click here to add this to my saved trials
Dallas, Texas 75208
Principal Investigator: Roger Bedimo, MD, MS
Phone: 972-807-7370
Click here to add this to my saved trials
Greensboro, North Carolina 27401
Principal Investigator: Cornelius Van Dam, MD
Phone: 336-832-3262
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Roberto C. Arduino, MD
Phone: 713-500-6718
Click here to add this to my saved trials
Los Angeles, California 90035
Principal Investigator: Raphael Landovitz, MD
Phone: 310-206-6414
Click here to add this to my saved trials
Los Angeles, California 90033
Principal Investigator: Fred Sattler, MD
Phone: 323-343-8283
Click here to add this to my saved trials
Miami, Florida 33139
Principal Investigator: Margaret A. Fischl, MD
Click here to add this to my saved trials
Nashville, Tennessee 37204
Principal Investigator: David Haas, MD
Phone: 615-936-8516
Click here to add this to my saved trials
New York, New York 10010
Principal Investigator: Timothy Wilkin, MD, MPH
Phone: 212-746-4177
Click here to add this to my saved trials
New York, New York 10011
Principal Investigator: Marshall J. Glesby, MD
Phone: 212-746-4393
Click here to add this to my saved trials
New York, New York 10032
Principal Investigator: Magdalena Sobieszczyk, MD, MPH
Phone: 212-305-3178
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
Principal Investigator: Pablo Tebas, MD
Phone: 215-349-8092
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
Principal Investigator: Sharon Riddler, MD, MPH
Phone: 412-383-1675
Click here to add this to my saved trials
Providence, Rhode Island 02906
Principal Investigator: Karen T. Tashima, MD
Phone: 401-793-4396
Click here to add this to my saved trials
Rochester, New York 14642
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Principal Investigator: David Clifford, MD
Phone: 1-314-747-1098
Click here to add this to my saved trials
San Diego, California 92103
Principal Investigator: Constance A. Benson, MD
Phone: 619-543-3094
Click here to add this to my saved trials
San Francisco, California 94110
Principal Investigator: Diane V. Havlir, MD
Phone: 415-476-4082
Click here to add this to my saved trials
San Juan, 00935
Principal Investigator: Jorge L Santana-Bagur, MD
Phone: 1-787-767-9192
Click here to add this to my saved trials
Seattle, Washington 98104
Principal Investigator: Ann C Collier, MD
Phone: 206-744-8886
Click here to add this to my saved trials
Torrance, California 90502
Principal Investigator: Eric S. Daar, MD
Phone: 310-222-3848
Click here to add this to my saved trials