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HIV-1 InfectionPhase 2NCT01403051

High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART

A Phase 2 study testing EFV/FTC/TDF, Calcium Carbonate and Vitamin D3 in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 39 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was done with people who were infected with HIV and needed to start treatment for their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will help prevent the bone loss that sometimes happens when people start HIV treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
EFV/FTC/TDF, Calcium Carbonate and Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
167 participants
Where
39 sitesin 2 countries
Study dates
Sep 2011to Feb 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV-1 infection
  • No evidence of any exclusionary resistance mutations based on results from any genotype assay from any laboratory that has a CLIA (Clinical Laboratory Improvement Amendments) certification or its equivalent. Results must be available from testing any time in the past or must be obtained prior to entry and reviewed by the site investigator.
  • ARV drug-naïve (<=10 days of ART at any time prior to entry) and no ARV drugs taken within the past 30 days.
  • CD4+ cell count of any value obtained within 90 days prior to study entry at any laboratory that has a CLIA certification or its equivalent.
  • HIV-1 RNA >1000 copies/mL obtained within 90 days prior to study entry at any laboratory that has a CLIA certification or its equivalent.
  • Certain laboratory values obtained within 30 days prior to entry (as indicated in section 4.1.6 of the protocol.
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  • Serum calcium < 10.5 mg/dL within 30 days prior to entry.
  • For women of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to initiating study medications.
  • Subjects must refrain from participating in a conception process (i.e., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two of the reliable forms of contraceptive listed in section 4.1.9 of the protocol.
  • 25-OH vitamin D >=10 ng/mL and <75 ng/mL.
  • Ability and willingness of subject or legally authorized representative to provide informed consent.

Who cannot join

  • Current or prior use of bisphosphonate therapy.
  • Use of vitamin D supplements greater than 800 IU/day within 30 days prior to entry.
  • Use of calcium supplements greater than 500 mg/day within 30 days prior to entry.
  • Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.
  • Any oral, intravenous, or inhaled steroids within the 30 days prior to enrollment(intranasal steroid use is allowed).
  • Use of androgenic hormones or growth hormones.
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  • Receipt of systemic cytotoxic chemotherapy within 30 days prior to entry.
  • Pregnancy or currently breastfeeding.
  • Documentation of acute opportunistic infections within 30 days prior to entry.
  • Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to entry.
  • Weight >300 lbs (exceeds weight limit of DXA scanners).
  • History of nephrolithiasis (kidney stones).
  • History of osteoporosis (as documented by DXA scan) or fragility fracture.
  • Clinically active thyroid disease (use of thyroid hormone replacement therapy permitted but TSH must be in normal range).
  • Current imprisonment or involuntary incarceration in a medical facility for psychiatric illness.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.

Trial locations and contacts

39 sites in 2 countries.

39 sites in 2 countries

United States38 sites

  • The Ponce de Leon Ctr. CRS (5802)

    Atlanta, Georgia, 30308

  • University of Colorado Hospital CRS (6101)

    Aurora, Colorado, 80045

  • IHV Baltimore Treatment CRS (4651)

    Baltimore, Maryland, 21201

  • Alabama Therapeutics CRS (5801)

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital ACTG CRS (101)

    Boston, Massachusetts, 02114

  • Brigham and Women's Hosp. ACTG CRS (107)

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Med. Ctr., ACTG CRS (103)

    Boston, Massachusetts, 02215

  • Unc Aids Crs (3201)

    Chapel Hill, North Carolina, 27514

  • Northwestern University CRS (2701)

    Chicago, Illinois, 60611

  • Rush University Medical Center (2702)

    Chicago, Illinois, 60612

  • Univ. of Cincinnati CRS (2401)

    Cincinnati, Ohio, 45267

  • Case CRS (2501)

    Cleveland, Ohio, 44106

  • MetroHealth CRS (2503)

    Cleveland, Ohio, 44109

  • The Ohio State Univ. AIDS CRS (2301)

    Columbus, Ohio, 43210

  • Trinity Health and Wellness Center CRS (31443)

    Dallas, Texas, 75208

  • Duke University Medical Center Adult CRS (1601)

    Durham, North Carolina, 27710

  • Regional Center for Infectious Disease, Wendover Medical Center CRS (3203)

    Greensboro, North Carolina, 27401

  • Houston AIDS Research Team CRS (31473)

    Houston, Texas, 77030

  • Usc Crs (1201)

    Los Angeles, California, 90033

  • UCLA CARE Center CRS (601)

    Los Angeles, California, 90095

  • Vanderbilt Therapeutics CRS (3652)

    Nashville, Tennessee, 37232

  • Cornell CRS (7804)

    New York, New York, 10011

  • NY Univ. HIV/AIDS CRS (401)

    New York, New York, 10016

  • HIV Prevention & Treatment CRS (30329)

    New York, New York, 10032

  • New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477)

    Newark, New Jersey, 07103

  • Stanford CRS (501)

    Palo Alto, California, 94304

  • Hosp. of the Univ. of Pennsylvania CRS (6201)

    Philadelphia, Pennsylvania, 19104

  • Pittsburgh CRS (1001)

    Pittsburgh, Pennsylvania, 15213

  • The Miriam Hosp. ACTG CRS (2951)

    Providence, Rhode Island, 02906

  • AIDS Care CRS (1108)

    Rochester, New York, 14642

  • University of Rochester ACTG CRS (1101)

    Rochester, New York, 14642

  • Ucsd, Avrc Crs (701)

    San Diego, California, 92103

  • Ucsf Aids Crs (801)

    San Francisco, California, 94110

  • University of Washington AIDS CRS (1401)

    Seattle, Washington, 98104

  • Washington University CRS (2101)

    St Louis, Missouri, 63110

  • Bronx-Lebanon Hosp. Ctr. CRS (31469)

    The Bronx, New York, 10457

  • Harbor-UCLA Med. Ctr. CRS (603)

    Torrance, California, 90502

  • Georgetown University CRS (GU CRS) (1008)

    Washington D.C., District of Columbia, 20007

Other trials in United States

Puerto Rico1 site

  • Puerto Rico-AIDS CRS (5401)

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Prospective, Randomized, Double-Blind Phase II Trial of High-Dose Vitamin D and Calcium for Bone Health in HIV-Infected Individuals Initiating Highly Active Antiretroviral Therapy (HAART)

This study was done with people who were infected with HIV and needed to start treatment for their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will help prevent the bone loss that sometimes happens when people start HIV treatment. For this study, the following HIV treatment (or HAART) were provided in the form of a single tablet that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). These drugs are approved by the FDA to treat HIV infection. The HIV treatment provided is common for people who are taking HIV drugs for the first time. The risks seen with this HIV treatment are the same that you would encounter when taking these drugs outside of the study. The lists of risks of this HIV treatment are included in this document because the drugs are provided by the study, not because the drugs are being tested. The purpose of the study is only to look at the impact of high doses of vitamin D and calcium in preventing bone loss. There are no study objectives related to HIV treatment (EFV/FTC/TDF).

Conditions
HIV-1 Infection
Being tested
EFV/FTC/TDF, Calcium Carbonate, Vitamin D3, Placebo for calcium carbonate, Placebo for vitamin D3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EFV/FTC/TDFDrug

    Also called Atripla

    FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.

  • Calcium CarbonateDrug

    Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.

  • Vitamin D3Drug

    One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.

  • Placebo for calcium carbonateDrug

    A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks

  • Placebo for vitamin D3Drug

    A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.

Study groups in NCT01403051
Study groupRoleWhat they receive
Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonateExperimentalParticipants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), calcium carbonate and vitamin D3 4000 IU.
Receives: Drug: EFV/FTC/TDF; Drug: Calcium Carbonate; Drug: Vitamin D3
Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placeboExperimentalParticipants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), a placebo for calcium carbonate, and a placebo for vitamin D3.
Receives: Drug: EFV/FTC/TDF; Drug: Placebo for calcium carbonate; Drug: Placebo for vitamin D3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip

    The efficacy endpoint is the percent change from baseline to week 48 in bone mineral density (BMD) at total hip (as measured by DXA scan)

    Measured: Weeks 0 and 48

Secondary outcomes (13)

  1. The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine

    The percent change from baseline to week 48 in bone mineral density (BMD) at spine as measured by DXA scan

    Measured: Weeks 0 and 48

  2. Number of Participants With Primary Adverse Events

    Primary adverse events include all SAEs defined according to ICH guidelines and targeted protocol events, which include all diagnoses of hypercalcemia, hypophoatemia, and nephrolithiasis as well as signs and symptoms grade 2 or higher that may be associated with hypercalcemia and all laboratory toxicities grade 2 or higher defined by the 2004 DAIDS grading table

    Measured: From first study treatment to week 48

  3. The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48

    Changes in total 25-OH vitamin D from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

    Total 25-OH vitamin D is the sum of vitamin 25-OH D2 and D3 levels. All 25-OH vitamin D2 or D3 values below the lower limit of 1.25 ng/mL were imputed to 0 ng/mL

    Measured: Weeks 0, 24, and 48

  4. The Changes From Baseline in IL-6 to Weeks 24 and 48

    Interleukin 6 (IL-6) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

    Measured: Weeks 0, 24 and 48

  5. The Changes From Baseline in sCD14 to Weeks 24 and 48

    Soluble cluster of differentiation 14 (sCD14) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

    Measured: Weeks 0, 24 and 48

  6. The Changes From Baseline in P1NP to Weeks 24 and 48

    P1NP (marker of bone formation) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

    Measured: Weeks 0, 24 and 48

  7. The Changes From Baseline in CTX to Weeks 24 and 48

    CTX (marker of bone resorption) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

    Measured: Weeks 0, 24 and 48

  8. The Changes From Baseline in HOMA-IR to Weeks 24 and 48

    Homeostatic model assessment insulin resistance (HOMA-IR) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

    Measured: Weeks 0, 24 and 48

  9. The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48

    Fasting total cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

    Measured: Weeks 0, 24 and 48

  10. The Changes From Baseline in Fasting LDL to Weeks 24 and 48

    Fasting LDL cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

    Measured: Weeks 0, 24 and 48

  11. The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48

    Fractional excretion of phosphate changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

    Fractional Excretion of Phosphate (in %) is defined as:

    [Urine Phosphate x Serum Creatinine] / [Urine Creatinine x Serum Phosphate] x 100%

    Measured: Weeks 0, 24 and 48

  12. The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48

    Total CD4 count changes from baseline to weeks 4, 12, 24 and 48 [week 4/12/24/48 - baseline].

    Measured: Weeks 0, 4, 12, 24 and 48

  13. The Changes From Baseline in iPTH to Weeks 24 and 48

    iPTH (Parathyroid Hormone, intact) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

    Measured: Weeks 0, 24 and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01403051
Sponsor's protocol ID
ACTG A5280
Other IDs
1U01AI068636
Status last verified
Sep 2018
First submitted
25 Jul 2011
Last updated
12 Oct 2018
Data monitoring committee
Yes

Publications

  • Yin MT, Chan ES, Brown TT, Kinslow J, Martinson J, Landay A, Melbourne KM, Ribaudo HJ, Overton ET; A5280 Study Team. Vitamin D does not modulate immune-mediated bone loss during ART initiation. Antivir Ther. 2019;24(5):355-362. doi: 10.3851/IMP3316.

    PubMed 31085814

  • Yin MT, Chan ES, Brown TT, Tebas P, McComsey GA, Melbourne KM, Napoli A, Hardin WR, Ribaudo HJ, Overton ET; A5280 Study Team. Racial differences in calculated bioavailable vitamin D with vitamin D/calcium supplementation. AIDS. 2017 Nov 13;31(17):2337-2344. doi: 10.1097/QAD.0000000000001621.

    PubMed 28832406

  • Overton ET, Chan ES, Brown TT, Tebas P, McComsey GA, Melbourne KM, Napoli A, Hardin WR, Ribaudo HJ, Yin MT. Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial. Ann Intern Med. 2015 Jun 16;162(12):815-24. doi: 10.7326/M14-1409.

    PubMed 26075752

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EFV/FTC/TDF, Calcium Carbonate and Vitamin D3 in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 39 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip (time frame: Weeks 0 and 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01403051, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.

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