Testing the Safety and Efficacy of Commercial Drug Biktarvy in Subjects Known to Have the 184 Resistance Mutation to a Component in Biktarvy
Verified August 2019 by Southampton Healthcare, Inc.
Southampton Healthcare, Inc.
Information provided by (Responsible Party)
Southampton Healthcare, Inc.
First received: July 11, 2019
Last updated: August 12, 2019
Last Verified: August 2019
History of Changes
An Open-Label Study to Evaluate Switching from a Regimen of Elvitegravir/Tenofovir alafenamide/Emtricitabine/Cobicistat and Darunavir, to a Fixed-Dose Combination of Bictegravir/Tenofovir alafenamide/Emtricitabine in Virologically Suppressed HIV-1 Subjects who are known to have a I84 V/I Mutation
Drug : Biktarvy Tab
Intervention Model: Single Group Assignment
Intervention Model Description: subjects under current treatment for HIV with the I84 I/V Mutation Resistance
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Open-label Switch Study From a Regimen of Elvitegravir/Tenofovir Alafenamide/Emtricitabine/Cobicistat and Darunavir, to a FDC of Bictegravir/Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed HIV-l Subjects Known to Have an 184 V/I Mutation|
Further study details as provided by Southampton Healthcare, Inc.:
Primary Outcome Measures
Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation.
[ Time Frame: In 48 week study ]
Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 12.
- Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184 V/I resistance mutation.
[ Time Frame: In 48 Week study ]
Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 24.
- Test the safety and effectiveness of the drug Biktarvy in subjects known to have the 184
[ Time Frame: 48 Weeks ]
Pure Virologic Response (PVR) with HIV-1 RNA < 50 copies/mL at week 48
|Study Start Date:||July 1, 2019|
|Estimated Study Completion Date:||December 31, 2020|
|Estimated Primary Completion Date:||December 31, 2020 (Final data collection date for primary outcome measure)|
Open label Biktarvy to establish suppression of HIV 1 with 184 V/I Resistance Mutation
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- The ability to understand and sign a written informed consent which must be obtained prior to initiation of study procedures.
- Age equal to or greater than 18 years.
- Currently receiving an ARV regimen of EVG/F/TAF +DRV greater than six month.
- Documented plasma HIV - 1 RNA less than 50 copies/ml during the treatment with Elvitegravir/F/TAF for a minimum of 12 months prior to screening, on two separate determinations, with one determination within 3 months prior to screening.
- Have a documented 184 V/I resistant mutation.
- HIV-1 RNA levels < 50 copies per ml at screening.
- Estimated GFR >than or equal to 30 mls/min.
- AST and ALT equal to or less than 5 times upper limit of normal.
- Total bilirubin less than or equal to 1.5 mg/dl or normal direct bilirubin.
- Adequate hematologic function (absolute neutrophil count equal to or greater than 750/mm to the third, platelets equal to or greater than 50,000/mm to the third, Hemoglobin equal to or greater than 8.5 g/dl).
- Persons of child bearing potential must have negative serum pregnancy test at screening.
- Male participants and persons of child bearing potential who engage in heterosexual intercourse must agree to use our protocol specified methods of contraception.
- Female participants must agree to refrain from egg donation from first dose of FDC of B/F/TAF and throughout the study.
- Male participants must agree to refrain from sperm donation from first dose until at least 30 days after last dose of drug.
- Life expectancy equal to or greater than one year.
- No desire to switch from current antiretroviral treatment.
- Any previous use of B/F/TAF.
- Any opportunistic illness indicative of stage 3 HIV diagnosed within 30 days prior to screening.
- Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completed resected non melanoma skin cancer, basal cell carcinoma, or noninvasive cutaneous squamous carcinoma, or completed resected carcinoma in situ of the cervix or anus. A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least 5 years prior to screening.
- Known hypersensitivity to FDC of B/F/TAF tablets their metabolites or formulation.
- No active treatment of Hepatitis C during the 48 weeks of the study.
- Females who are pregnant confirmed by serum pregnancy test.
- Females who are breast feeding.
- Suspected Biktarvy resistance mutations, except 184 V/I.
- Patients who need to take Dofetilide, Rifampin, Rifapentine, Rifabutin, phenobarbital, phenytoin, carbamazepine, oxcarbazepine, and antiretrovirals not part of the study and St. John's Wart during.
- Acute Hepatitis in the 30 days prior to screening.
- Active tuberculosis infection.
- Current alcohol or substance use judged by the investigator to potentially interfere
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT04040075
Locations Show More
|United States, Missouri|
|Southampton Healthcare, Inc.||Recruiting|
|Saint Louis, Missouri, United States, 63139|
Contact: Kelle Thompson, CRC  314-647-2200 ext 116  email@example.com
Contact: Cindy Tobias, R.N.  1-314-647-2200 ext 114  firstname.lastname@example.org
Principal Investigator: David J Prelutsky, M.D.
Sub-Investigator: Tassy N Hayden, M.D.
Sub-Investigator: Sam T Tochtrop, D.O.
Sponsors and CollaboratorsSouthampton Healthcare, Inc.
|Responsible Party:||Southampton Healthcare, Inc.|
|ClinicalTrials.gov Identifier:||NCT04040075 History of Changes|
|Other Study ID Numbers:||184 Resistance Study|
|Study First Received:||July 11, 2019|
|Last Updated:||August 12, 2019|
|Individual Participant Data|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
ClinicalTrials.gov processed this data on May 28, 2020
This information is provided by ClinicalTrials.gov.