Effect of Reducing Nucleotide Exposure on Bone Health (ReNew)



Status:Not yet recruiting
Conditions:Osteoporosis, HIV / AIDS, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:August 1, 2019
End Date:July 1, 2021
Contact:Kevin M Morrison
Email:kmmorris@stanford.edu
Phone:(650) 497-4057

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This is an open-label, randomized pilot study to assess the effect on bone mineral density
(BMD) of a switch from a tenofovir alafenamide-containing antiretroviral regimen to
dolutegravir/lamivudine vs. a continuation of the tenofovir alafenamide-containing regimen.


Inclusion Criteria:

1. HIV-1 infection, as documented by a positive 4th generation assay or by any licensed
ELISA test kit confirmed by Western blot at any time prior to study entry.

2. Age ≥18 years

3. HIV-1 RNA BLQ (e.g., <20 copies/mL or other threshold based on the local viral load
assay used) for at least 12 months prior to study entry excluding blips (i.e., a
single measurement <200 copies/mL preceded and followed by measurements BLQ)

4. On a stable TAF-containing ART that also includes at least 2 other antiretrovirals,
with no changes in the 12 months prior to entry (except for a switch to a
co-formulated tablet from the component tablets or a switch from ritonavir to
cobicistat)

5. Lumbar spine, femoral neck or total hip BMD T-score ≤-1.0 from a DXA scan within the
past 48 weeks

6. If receiving testosterone or estrogen replacement therapy, on a stable dose for ≥3
months prior to enrollment without plan to change dose during the study period.

7. Acceptable blood laboratory values at screening visit:

- CD4+ T-cell count ≥200 cells/µL

- Phosphate ≥2mg/dL

- 25-hydroxyvitamin D level ≥10 ng/ml

- Calculated creatinine clearance (CrCl) ≥50 mL/min as estimated by the
Cockcroft-Gault equation*:

- For men = CrCl (mL/min) = (140 - age in years) x (body weight in kg) ÷
(serum creatinine in mg/dL x 72)

For women, multiply the above result by 0.85

8. For women of reproductive potential, negative serum or urine pregnancy test prior to
screening and a negative urine pregnancy test at the entry visit prior to
randomization and agreeable to using a contraceptive of choice during the study
period.

"Women of reproductive potential" are defined as women who have not been post-menopausal
for at least 24 consecutive months (i.e., who have had menses within the preceding 24
months) and have not undergone surgical sterilization (i.e., hysterectomy, bilateral
oophorectomy, or tubal ligation; participant report sufficient)

Exclusion Criteria:

1. Current systemic glucocorticoid use

2. Lumbar spine, femoral neck or total hip BMD T-score <-3.0

3. Previous, current pharmacologic treatment, or plan for initiation of therapy for
osteoporosis (i.e., bisphosphonates, teriparatide, denosumab, tamoxifen or raloxifene)

4. Previous fragility fracture (i.e., any fall from a standing height or less that
resulted in a fracture)

5. History of genotypic resistance or phenotypic resistance to either DTG or 3TC. The
interpretation of genotypic resistance is based on output from the Stanford HIV
Resistance Database (available at https://hivdb.stanford.edu). Isolates with an
interpretation of low-level resistance or higher are considered resistant.

6. History of virologic failure (i.e., confirmed HIV-1 RNA level ≥200 copies/mL after
over 6 months of therapy) while on an integrase inhibitor (i.e., raltegravir,
elvitegravir, bictegravir, or dolutegravir) or on lamivudine/emtricitabine prior to
study enrollment. Any antiretroviral history (even before routine virologic monitoring
became standard of care) that would suggest the presence of the M184V mutation should
be considered exclusionary

7. ALT ≥5 X ULN, OR ALT ≥3xULN and bilirubin ≥1.5xULN (with >35% direct bilirubin)

8. Severe hepatic impairment (Child Pugh Class C)

9. Anticipated need for antiviral therapy for HCV

10. Hepatitis B surface antigen positive or Hepatitis B DNA positive

11. Weight >300 pounds, precluding safe DXA testing

12. Breastfeeding, pregnancy, or plans to become pregnant during the study

13. Known allergy/sensitivity to DTG or 3TC.

14. Receipt or planned receipt of prohibited concomitant medications (See section 5.4)

15. Active drug or alcohol use or dependence that, in the opinion of the site
investigator, would interfere with adherence to study procedures and treatment.

16. Any serious medical or psychiatric illness that, in the opinion of the site
investigator, precludes safe participation or adherence to study procedures.
We found this trial at
10
sites
Atlanta, Georgia
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Aurora, Colorado 80045
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Baltimore, Maryland 21218
(410) 516-8000
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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Chicago, Illinois 49201
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4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
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Houston, Texas 77030
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New York, New York 10032
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New York, NY
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Palo Alto, California 94304
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Palo Alto, CA
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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