Study Comparing DTG/3TC and BIC/FTC/TAF for Maintaining HIV Control in Adults

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What is this study about?

This clinical trial is focused on studying the treatment of HIV, a virus that attacks the body’s immune system. The study involves two different treatments. The first treatment is a medication called Dovato, which contains the active substances lamivudine and dolutegravir sodium. The second treatment is a medication called Biktarvy, which includes the active substances emtricitabine, tenofovir alafenamide, and bictegravir (also known by the code name GS-9883). Both medications are taken as film-coated tablets.

The purpose of this study is to compare the effectiveness of these two treatments in maintaining control over the virus in people living with HIV. Participants in the study will be randomly assigned to receive either Dovato or Biktarvy. The study will last for a period of up to 96 weeks, during which participants will take their assigned medication daily. Throughout the study, participants will have regular check-ups to monitor their health and the level of the virus in their blood.

This trial aims to determine if Dovato is as effective as Biktarvy in keeping the virus under control. Participants will be closely monitored to ensure their safety and to gather information on how well each treatment works. The study is designed to provide valuable insights into the management of HIV, potentially leading to improved treatment options for those living with the virus.

1 joining the study

Upon joining the study, the participant must provide written informed consent after understanding the study information.

Eligibility is confirmed by meeting criteria such as being 18 years or older, having a confirmed HIV infection, and maintaining HIV RNA levels below 50 copies/mL for at least 24 weeks before screening.

2 initial assessment

An initial medical evaluation is conducted, including a review of medical history, laboratory tests, and cardiac monitoring to ensure clinical stability.

Females of childbearing potential must use effective contraception and undergo urine pregnancy testing at specified times.

3 randomization and treatment

Participants are randomly assigned to one of two treatment groups: DTG/3TC or BIC/FTC/TAF.

DTG/3TC group receives Dovato 50 mg/300 mg film-coated tablets, taken orally.

BIC/FTC/TAF group receives Biktarvy 50 mg/200 mg/25 mg film-coated tablets, taken orally.

4 treatment duration

The treatment is administered continuously until the estimated end date of the trial on January 1, 2025.

Participants are monitored for the maintenance of virological suppression throughout the study.

5 monitoring and follow-up

Regular follow-up visits are scheduled to monitor the participant’s health and the effectiveness of the treatment.

The primary endpoint is the proportion of patients with plasma HIV-1 RNA levels of 50 copies/mL or higher.

Who Can Join the Study?

Understand the study information provided and be capable of giving written informed consent.
Have a confirmed HIV infection.
Be 18 years of age or older on the day of screening.
Have HIV RNA (a measure of the virus in the blood) less than 50 copies/mL for at least 24 weeks before screening.
Be receiving any treatment for HIV that includes more than one pill a day or a single tablet that contains certain medications like cobicistat-boosting, efavirenz, or tenofovir disoproxyl fumarate, for at least 24 weeks before screening. There are specific conditions for those taking TAF (a type of medication).
Have no evidence of previous viral failure (when the virus is not controlled by treatment).
Have no known or suspected resistance to the study drugs (when the virus does not respond to the medication).
If female and able to have children, must use highly effective methods of contraception from study inclusion and for at least 4 weeks after the last study visit. All female volunteers must agree to undergo urine pregnancy testing at specified times.
Be in clinical stability, meaning participants should be healthy (other than having HIV) as determined by a medical evaluation, which includes medical history, laboratory tests, and heart monitoring.

Who Cannot Join the Study?

Individuals who do not have HIV cannot participate. HIV is a virus that affects the immune system.
Participants must be adults, meaning they should be of a certain age, typically 18 years or older.
Both men and women can participate, but they must meet all other criteria.
Individuals who are part of a vulnerable population, such as those who may not be able to give informed consent, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Hospital Marina Baixa De La Vila Joiosa	Villajoyosa	Spain
Hospital Universitario Torrecardenas	Almeria	Spain
Hospital Universitari Joan XXIII De Tarragona	Tarragona	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hospital Son Llatzer	Palma	Spain
Hospital Universitario Virgen De Valme	Sevilla	Spain
Parc Sanitari Sant Joan De Deu	Sant Boi De Llobregat	Spain
Hospital Alvaro Cunqueiro	Vigo	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Hospital Costa del Sol	Marbella	Spain
Hppqnqig Ufmcoeboudwvy Dh Lp Psbixehy	Madrid	Spain
Hknoxfjm De Lm Shmwm Cjnn I Satf Ptb	Barcelona	Spain
Fjnsusxnt Pkud Ln Ifuzczidzogxk Bkzkpwuij Daj Hsrbzezl Uqpbspztjngat Lr Pyi	Madrid	Spain
Hivxyskd Ueczivkvuvkbw Hihvkovx Tsjsg y Pposvk Iolnieqp Clmaor deradecmkvfejioce (jarz	Badalona	Spain
Huwbdbmh Varg dqhdbzvd	Barcelona	Spain
Hnoeohyg Ugrkixwujkhmd dq A Cixyvi	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	14.07.2021

Trial locations

Investigated drugs:

DTG/3TC is a combination of two medications used to maintain control of HIV in people who are already virologically suppressed. It helps keep the virus at low levels in the body, preventing it from multiplying and causing harm.

BIC/FTC/TAF is another combination of three medications used for the same purpose of maintaining control of HIV in people who are already virologically suppressed. This combination also works to keep the virus at low levels, helping to prevent the progression of the disease.

Investigated diseases:

HIV infection

Human Immunodeficiency Virus (HIV) Infection – HIV is a virus that attacks the body’s immune system, specifically the CD4 cells (T cells), which are crucial for fighting infections. Over time, HIV can destroy so many of these cells that the body can’t fight off infections and disease. The virus is transmitted through contact with certain body fluids of an infected person, most commonly during unprotected sex or through sharing needles. In the early stages, many people experience flu-like symptoms, but as the infection progresses, it can lead to more severe health issues. Without treatment, HIV can advance to Acquired Immunodeficiency Syndrome (AIDS), where the immune system is severely damaged. However, with proper medical care, HIV can be controlled, and individuals can live long, healthy lives.

Trial ID:

2024-515167-56-00

Protocol code:

GESIDA 11720

NCT ID:

NCT04884139

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study Comparing DTG/3TC and BIC/FTC/TAF for Maintaining HIV Control in Adults

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