CLINICAL TRIAL

DTG/3TC FDC for HIV Infections

Waitlist Available · 18+ · All Sexes · Sevilla, Spain

This study is evaluating whether a new drug combination is as effective as current drugs in suppressing HIV.

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About the trial for HIV Infections

Treatment Groups

This trial involves 2 different treatments. DTG/3TC FDC is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
DTG/3TC FDC
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
CAR
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
i) Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability and/or safety concerns or access to medications, or convenience/simplification and must not have been done for suspected or established treatment failure. The following switches, if they are the only switches, would not be considered a change in regimen. a) A switch from a PI boosted with ritonavir (RTV) to the same PI boosted with cobicistat is allowed (and vice versa). b) A switch from 3TC to emtricitabine (FTC) (and vice versa). c) A switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) (and vice versa).
A female participant is eligible to participate if she is not pregnant [as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screen and a negative urine hCG test at randomization (a local serum hCG test at randomization is allowed if it can be done, and results obtained, within 24 hours prior to randomization)], not breastfeeding, and at least one of the following conditions applies; not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period from 28 days prior to the first dose of study medication and for at least 2 weeks after the last dose of study medication. All participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner; The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Eligible participants must be able to understand and comply with protocol requirements, instructions, and restrictions; participant must be likely to complete the study as planned; participants should be considered appropriate candidates for participation in an investigative clinical trial with oral medication (example given [e.g.] no active problematic substance abuse, acute major organ disease, or potential long-term work assignments out of the country).
Participant should be aged 18 years or older (or older, if required by local regulatory agencies), at the time of signing the informed consent.
Participants living with HIV.
Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening.
Plasma HIV-1 RNA <50 c/mL at Screening.
Participant must be on uninterrupted current regimen (either the initial or second Combination antiretroviral therapy [cART] regimen) for at least 3 months prior to Screening.
ii) Acceptable stable cART regimens prior to Screening include 2 NRTIs plus a) INI (either the initial or second cART regimen) b) NNRTI (either the initial or second cART regimen) c) Boosted PI (or atazanavir [ATV] unboosted) (either the initial or second PI-based cART regimen).
A male or female participant.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 52 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 52 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 52 weeks.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether DTG/3TC FDC will improve 1 primary outcome and 21 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of Baseline and Week 24.

Change from Baseline in fasting lipids at Week 24
BASELINE AND WEEK 24
Lipid parameters will include total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides.
BASELINE AND WEEK 24
Change from Baseline in health status by Symptom Distress Module (SDM) at Week 24
BASELINE AND WEEK 24
The health status of participants will be evaluated using SDM. It is also known as HIV Symptom Index or Symptoms Impact Questionnaire, which is 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment.
BASELINE AND WEEK 24
Change from Baseline in CD4+/ cluster of differentiation 8 (CD8+) cell counts ratio for Week 24
BASELINE AND WEEK 24
Lymphocyte subsets will be collected for assessment by flow cytometry. Change from Baseline in CD4+/CD8+ cell count ratio will be assessed at Week 24 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets will be collected.
BASELINE AND WEEK 24
Change from Baseline in health status by HIV treatment satisfaction questionnaire (TSQ) at Week 24
BASELINE AND WEEK 24
The health status of participants will be evaluated using HIV TSQ. HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains
BASELINE AND WEEK 24
Change from Baseline in cluster of differentiation 4 (CD4+) cell count for Week 24
BASELINE AND WEEK 24
Lymphocyte subsets will be collected for assessment by flow cytometry. Change from Baseline in CD4+ lymphocyte count will be assessed at Week 24 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets will be collected.
BASELINE AND WEEK 24
Number of participants with plasma HIV-1 RNA <50 c/mL using the Snapshot algorithm at Week 24
WEEK 24
Number of participants with plasma HIV-1 RNA <50 c/mL will be evaluated using the FDA snapshot algorithm at Week 24 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 24 weeks. Plasma samples for HIV-1 RNA will be collected at Week 24.
WEEK 24
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get hiv infections a year in the United States?

HIV prevalence has generally been decreasing since the mid-1990s. The current HIV prevalence rate of U.S. men who have sex with men and transgender people is 0.8%. A similar rate was found in the U.S. general population in the 2016 CDC AIDS Surveillance Report.\n

Anonymous Patient Answer

What is the latest research for hiv infections?

HIV infection appears to play an important role in the pathogenesis of BMT. Furthermore, it may play an important role in the pathogenesis of other autoimmune diseases in patients with BMT. However, the exact role of HIV infection in BMT remains to be elucidated by future studies.

Anonymous Patient Answer

What is hiv infections?

Although there are a wide range of symptoms experienced by people living with HIV/AIDS, the most common and easily recognized symptom is low grade fever. Other clinical features can include muscle pain and swollen lymph nodes. The risk of death increases considerably in those with advanced disease and infection with HIV.\n

Anonymous Patient Answer

Can hiv infections be cured?

There is no evidence that can be extrapolated from successful and complete response to HAART to suggest that an entire population of infected people can be eradicated. The concept of an asymptomatic, 'closet' culture must be overturned, and people with HIV must be treated and followed as they would be treated and followed to identify opportunistic infections and to prevent transmission.

Anonymous Patient Answer

What are common treatments for hiv infections?

Because of the high cost of standard HIV treatment, a number of strategies are used to combat HIV infection. No single strategy appears to solve all the problems associated with HIV infection. Effective HIV treatment options are focused primarily on lowering the viral load to a level that is below disease progression. At such a low level of viral load, other treatment modalities are often used as a backstop strategy if progress toward a cure for HIV is slow. However, new treatments for HIV-1 are likely to be needed to effectively combat HIV infection, as well as an improved understanding of the basic causes of HIV infection. Therefore, a number of different treatments have been used for HIV infection, but no single treatment is effective for all patients in all cases.

Anonymous Patient Answer

What causes hiv infections?

HIV is transmitted through heterosexual sexual intercourse and has spread very rapidly. It had not been previously recognized that an infected couple can contribute to the epidemic if their relationship goes beyond just casual sexual encounter. Sexual behavior is very risky, as HIV can be passed from men to women (during sexual intercourse) and women (during pregnancy), and from women to men. Therefore, it is important to educate people about the risk of hiv transmission. People with hiv can help prevent hiv by always using condoms when they are having sexual intercourse and to always be vigilant and use safe-sex practices. Preventing hiv is more practical than just trying to stop HIV because hiv cannot be cured or eradicated.

Anonymous Patient Answer

What are the signs of hiv infections?

Signs of AIDS may appear within a few weeks of the first symptoms of HIV infection even in individuals with no history of exposure to AIDS.

Anonymous Patient Answer

What are the common side effects of dtg/3tc fdc?

In this large, multi-center clinical trial, there was a wide spectrum of mild and moderate DDP-associated side effects that were reported by patients in this group and were not reported as commonly as more severe side effects, such as hepatitis, or opportunistic infections, e.g., candidiasis. While most of these effects were mild or moderate, some, such as fever and nausea, are more clinically significant due to their potential for patient morbidity and mortality. Therefore, dtg/3tc fdc, as presently recommended, must be used with caution while carefully considering drug-associated side effects.

Anonymous Patient Answer

Has dtg/3tc fdc proven to be more effective than a placebo?

The data show that DTG plus 3TC has an antiviral effect with no significant differences in efficacy to a control group of patients who received placebo. It is not possible to conclude that this is the result of the DTG/3TC combination. Moreover, DTG/3TC may have an increased risk of side effects compared with placebo.

Anonymous Patient Answer

What is the primary cause of hiv infections?

Findings from a recent study underscores the need to include HIV testing in clinical practice if we are to effectively and efficiently treat HIV-infected persons for their comorbid conditions.

Anonymous Patient Answer

Is dtg/3tc fdc typically used in combination with any other treatments?

All of the patients responded to the initial regimen of dtg/3tc fdc used in combination with the HAART that they had initiated. A combination of dtg/3tc fdc plus 3TC for 24-48 months is effective, with similar toxicity profiles as those reported for HAART-treated patients. It is not necessary to routinely add dTG to the combination in patients who achieve SVR or to switch to another antiretroviral formulation from that reported from HAART.

Anonymous Patient Answer

What is dtg/3tc fdc?

Drugs used in HIV therapy are not only efficacious in patients but also cost beneficial in the management of HIV and AIDS in a developing country such as Bhutan. However, there is a substantial gap between the availability and the usage of HAART in this country. The high cost coupled with the lack of access to medical professionals in the remote areas necessitate a review of our current HAART program. The introduction of combination therapy using NVP with FdC to make existing HAART drugs accessible to patients in Bhutan is very important.

Anonymous Patient Answer
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