Emtricitabine/Tenofovir Alafenamide as Salvage ART
Status:
Terminated
Trial end date:
2016-08-16
Target enrollment:
Participant gender:
Summary
Background:
HIV attacks the immune system. Antiretroviral therapy (ART) is a combination of drugs used
for treating HIV infection. For some people, ART drugs stop working against their HIV.
Researchers want to see if a different form of the drug tenofovir (an ART drug currently
approved by the FDA), combined with another drug, may help people whose HIV is resistant to
ART. This combination pill is called F/TAF
Objective:
To study the safety and efficacy of the drug F/TAF, when used with other ART, for people
whose HIV infection has been hard to control with available medicines.
Eligibility:
People age 14 years and older who have HIV infection and are enrolled in the DOTCOM
(14-I-0009) protocol.
Design:
Participants will be screened with physical exam, medical history, and blood and urine tests.
Participants will stay in the hospital for at least 10 days. For the first 9 days, they will
take F/TAF by mouth along with their usual ART drugs.
In the hospital, they will repeat the screening tests.
Participants will have a DEXA scan, an x-ray that measures calcium and other minerals in the
bones. Participants will lie on a soft table while the scanner passes over the lower spine
and hips.
Participants will get a supply of F/TAF and some new ART drugs to take at home.
Participants will have follow-up visits in 1, 2, 4, 8, and 12 weeks. After the 12-week visit,
they will come back about every 3 months for about 1 year.
At these visits, participants will repeat the screening tests. They will discuss any problems
taking their ART drugs. They may have another DEXA scan.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir