Phase 2
N=167
High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT01403051 ↗Enrolled (actual)
167
Serious AEs
9.0%
Results posted
Mar 2014
Primary outcome: Primary: The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip — -1.46; -3.19 percentage change — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EFV/FTC/TDF (Drug); Calcium Carbonate (Drug); Vitamin D3 (Drug); Placebo for calcium carbonate (Drug); Placebo for vitamin D3 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip |
-1.46; -3.19 | 0.001 sig |
| SECONDARY The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine |
-1.41; -2.91 | — |
| SECONDARY Number of Participants With Primary Adverse Events |
50; 53 | — |
| SECONDARY The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48 |
27.5; -0.8; 24.2; 0.6 | — |
| SECONDARY The Changes From Baseline in IL-6 to Weeks 24 and 48 |
-0.05; -0.04; -0.07; -0.03 | — |
| SECONDARY The Changes From Baseline in sCD14 to Weeks 24 and 48 |
0.02; 0.00; 0.07; 0.02 | — |
| SECONDARY The Changes From Baseline in P1NP to Weeks 24 and 48 |
11; 21; 15; 18 | — |
| SECONDARY The Changes From Baseline in CTX to Weeks 24 and 48 |
0.11; 0.22; 0.10; 0.14 | — |
| SECONDARY The Changes From Baseline in HOMA-IR to Weeks 24 and 48 |
0.17; 0.39; 0.13; 0.26 | — |
| SECONDARY The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48 |
11; 18; 13; 14 | — |
| SECONDARY The Changes From Baseline in Fasting LDL to Weeks 24 and 48 |
0; 8; 2; 4 | — |
| SECONDARY The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48 |
0.7; 0.2; 0; 0.9 | — |
| SECONDARY The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48 |
74; 60; 103; 106; 138; 136 | — |
| SECONDARY The Changes From Baseline in iPTH to Weeks 24 and 48 |
0.4; 4.2; 1.1; 5.2 | — |
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. 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).
Eligibility Criteria
Inclusion Criteria
- 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 ( 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.
- Serum calcium =10 ng/mL and 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.
Data sourced from ClinicalTrials.gov (NCT01403051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.