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Generated: June 26, 2019

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CLINICAL TRIALS PROFILE FOR DESCOVY

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Clinical Trials for Descovy

Trial ID Title Status Sponsor Phase Summary
NCT02957864 Switching From Tenofovir Disoproxil Fumarate to Abacavir or Tenofovir Alafenamide Recruiting Gilead Sciences Phase 4 Tenofovir disoproxil fumarate (TDF) is one of the most frequently used drugs to treat HIV. Long term use of TDF can induce renal toxicity. Tenofovir alafenamide (TAF) is a new pro-drug of Tenofovir which has not been associated with renal toxicity and may therefore be a good substitute for TDF in patients with TDF induced renal toxicity. Abacavir (ABC) is another drug that can be used for the treatment of HIV and is not associated with renal toxicity. In this study the investigators will compare the effect on renal function of a switch from TDF to TAF with a switch from TDF to ABC in patients with TDF induced renal insufficiency.
NCT02957864 Switching From Tenofovir Disoproxil Fumarate to Abacavir or Tenofovir Alafenamide Recruiting Erasmus Medical Center Phase 4 Tenofovir disoproxil fumarate (TDF) is one of the most frequently used drugs to treat HIV. Long term use of TDF can induce renal toxicity. Tenofovir alafenamide (TAF) is a new pro-drug of Tenofovir which has not been associated with renal toxicity and may therefore be a good substitute for TDF in patients with TDF induced renal toxicity. Abacavir (ABC) is another drug that can be used for the treatment of HIV and is not associated with renal toxicity. In this study the investigators will compare the effect on renal function of a switch from TDF to TAF with a switch from TDF to ABC in patients with TDF induced renal insufficiency.
NCT02962739 The Cellular Pharmacology of F-TAF in Dried Blood Spots Not yet recruiting University of Colorado, Denver Phase 1 Adherence to daily dosing is very important for how well Emtricitabine/Tenofovir Alafenamide (F/TAF) works for treatment of chronic HIV, or prevention of HIV acquisition. Methods to measure medication adherence to Tenofovir disoproxil fumarate (tenofovir DF, TDF), a similar but different prodrug of tenofovir, have been developed but cannot be extrapolated to F-TAF. By measuring F-TAF (the drug) and metabolites in the blood cells and dried blood spots, the study plans to see if these results predict adherence to taking the drug. The goal of this study is to vary the amount of F-TAF dosing and see if the drug levels in dried blood spots (DBS) change in a predictable way. This study will mimic different levels of adherence (33%, 67%, and 100% of daily dosing) using directly observed therapy (DOT) to establish the relationship between F-TAF in dried blood spots and adherence. Investigators will also measure drug in hair clippings to see if hair or DBS are a better predictor of adherence.
NCT03110380 Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Adults Who Are Virologically Suppressed Not yet recruiting Gilead Sciences Phase 3 The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine (Emtriva®)/tenofovir alafenamide (Descovy®; F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (Truvada®; F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance as determined by the proportion of participants with human immunodeficiency virus-1 ribonucleic acid (HIV-1 RNA) ≥ 50 copies/mL at Week 48
NCT03122262 ADVANCE Study of DTG + TAF + FTC vs DTG + TDF + FTC and EFV + TDF+FTC in First-line Antiretroviral Therapy Active, not recruiting Willem Daniel Francois Venter Phase 3 This is a non-inferiority (10% non-inferiority margin), study to assess the efficacy and safety of dolutegravir, DTG (50 mg once daily [QD]) administered in combination with tenofovir alafenamide fumarate, TAF (25 mg QD) and emtricitabine, FTC (200 mg QD) compared to DTG (50 mg QD) administered in combination with tenofovir disoproxil fumarate, TDF (300 mg QD) and FTC (200 mg QD) and compared to efavirenz, EFV (600 mg QD) administered in combination with TDF (300 mg QD) and FTC (200 mg QD) through 96 weeks in patients with HIV-1 starting first-line ART.
NCT03186482 RIFT: Effect of Rifampicin on Plasma PK of FTC, TAF and Intracellular TFV-DP & FTC-TP Recruiting St. Stephens Clinical Research Phase 1 The purpose of this study is to look at the levels of three HIV medications: Descovy®, Viread® and Rifadin® in the blood after drug intake has been stopped, in order to understand how long these drugs persist in the blood. The study will specifically look at blood levels of these three drugs after taking them every day for 28 days. Participants will take Descovy® on a first stage, a combination of Descovy® and Rifadin® on a second stage, and Viread® on a third stage. If the participants decide to take part, the duration of the study will be up to 85 days plus a screening visit which will take place up to 28 days prior to the start of the study, and a follow up visit, which takes place 28 to 36 days after the last dose of study medication. This study is not randomised which means that all participants will receive all study medications in the same order. The participant and the study doctor will know which study medications the participant is taking at all times during the study. During the study, numerous blood samples will be taken which could cause inconvenience and distress for patients. Every effort will be made by study staff to minimise this. There are a lot of clinic visits during the study and three full days in the unit which may inconvenience patients. However, participants will be made aware of this both verbally and in the patient information sheet. Participants will also receive compensation for their time and travel expenses whilst participating in the trial. Participants or participants' partners who plan to become pregnant during the study will not be allowed to take part in the study. Further to this (if applicable), participants must use effective contraception for the duration of the study. Participants will have to adhere to other restrictions as detailed in the participant information sheet. These restrictions will be explained in full to all participants.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Descovy

Condition Name

Condition Name for Descovy
Intervention Trials
Hiv 3
Healthy Volunteers 1
Therapeutic Agent Toxicity 1
Renal Insufficiency,Chronic 1
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Condition MeSH

Condition MeSH for Descovy
Intervention Trials
Renal Insufficiency, Chronic 1
Renal Insufficiency 1
Drug-Related Side Effects and Adverse Reactions 1
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Clinical Trial Locations for Descovy

Trials by Country

Trials by Country for Descovy
Location Trials
United Kingdom 1
South Africa 1
Netherlands 1
United States 1
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Trials by US State

Trials by US State for Descovy
Location Trials
Pennsylvania 1
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Clinical Trial Progress for Descovy

Clinical Trial Phase

Clinical Trial Phase for Descovy
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Descovy
Clinical Trial Phase Trials
Recruiting 3
Not yet recruiting 2
Active, not recruiting 1
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Clinical Trial Sponsors for Descovy

Sponsor Name

Sponsor Name for Descovy
Sponsor Trials
Gilead Sciences 3
St. Stephens Clinical Research 1
Willem Daniel Francois Venter 1
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Sponsor Type

Sponsor Type for Descovy
Sponsor Trials
Other 5
Industry 3
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