Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to... | NCT01533259 | Trialant

Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to... | NCT01533259 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Ability to understand and sign a written informed consent form

Virologically stable on the current first antiretroviral regimen consisting only of raltegravir twice daily plus FTC/TDF continuously for ≥ 6 months preceding the screening visit and

have documented undetectable plasma HIV-1 RNA levels ≥ 6 months preceding the screening visit (measured at least twice using the same assay) and

have never experienced two consecutive HIV-1 RNA above detectable levels after first achieving a confirmed HIV-1 RNA level below detectable levels on the first regimen

HIV-1 RNA < 50 copies/mL at the screening visit

Have a genotype prior to starting initial antiretroviral therapy and have no known resistance to any of the study agents at any time

Normal ECG

Hepatic transaminases ≤ 5 x upper limit of normal (ULN)

Total bilirubin ≤ 1.5 mg/dL

Adequate hematologic function

Serum amylase ≤ 5 x ULN

Estimated glomerular filtration rate ≥ 70 mL/min

Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner from screening throughout the duration of the study period and for 30 days following the last dose of study drug

Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing

Males must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product or must be non heterosexually active, practice sexual abstinence, or be vasectomized

Exclusion Criteria:

New AIDS defining condition diagnosed within the 21 days prior to screening

Females who are breastfeeding

Positive serum pregnancy test (female of childbearing potential)

Individuals with acute or chronic hepatitis B or hepatitis C co-infection

Individuals experiencing decompensated cirrhosis

Have an implanted defibrillator or pacemaker

Current alcohol or substance abuse that would interfere with compliance

A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma

Active, serious infections requiring parenteral antibiotic or antifungal therapy within 21 days prior to the baseline visit

Receiving any investigational drugs

Participation in any other clinical trial without prior approval from the sponsor

Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study

Any other clinical condition or prior therapy that would make the individual unsuitable for the study or unable to comply with the dosing requirements

Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural supplements during the study that are contraindicated or not recommended for use, including drugs not to be used with Stribild; or individuals with known allergies to the excipients of the Stribild single tablet regimen