Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT01403051
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 (\<=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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01403051
Study Brief:
Protocol Section:
NCT01403051