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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 39
- 主要终点
- The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonate
Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), calcium carbonate and vitamin D3 4000 IU.
干预措施: EFV/FTC/TDF (Drug)
Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonate
Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), calcium carbonate and vitamin D3 4000 IU.
干预措施: Calcium Carbonate (Drug)
Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonate
Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), calcium carbonate and vitamin D3 4000 IU.
干预措施: Vitamin D3 (Drug)
Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placebo
Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), a placebo for calcium carbonate, and a placebo for vitamin D3.
干预措施: EFV/FTC/TDF (Drug)
Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placebo
Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), a placebo for calcium carbonate, and a placebo for vitamin D3.
干预措施: Placebo for calcium carbonate (Drug)
Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placebo
Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), a placebo for calcium carbonate, and a placebo for vitamin D3.
干预措施: Placebo for vitamin D3 (Drug)
结局指标
主要结局
The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip
时间窗: Weeks 0 and 48
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)
次要结局
- The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine(Weeks 0 and 48)
- Number of Participants With Primary Adverse Events(From first study treatment to week 48)
- The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48(Weeks 0, 24, and 48)
- The Changes From Baseline in IL-6 to Weeks 24 and 48(Weeks 0, 24 and 48)
- The Changes From Baseline in sCD14 to Weeks 24 and 48(Weeks 0, 24 and 48)
- The Changes From Baseline in P1NP to Weeks 24 and 48(Weeks 0, 24 and 48)
- The Changes From Baseline in CTX to Weeks 24 and 48(Weeks 0, 24 and 48)
- The Changes From Baseline in HOMA-IR to Weeks 24 and 48(Weeks 0, 24 and 48)
- The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48(Weeks 0, 24 and 48)
- The Changes From Baseline in Fasting LDL to Weeks 24 and 48(Weeks 0, 24 and 48)
- The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48(Weeks 0, 24 and 48)
- The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48(Weeks 0, 4, 12, 24 and 48)
- The Changes From Baseline in iPTH to Weeks 24 and 48(Weeks 0, 24 and 48)