CLINICAL TRIAL

Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets for HIV Infections

Grade I
Waitlist Available · < 18 · All Sexes · Memphis, TN

This study is evaluating whether a combination of drugs may be safe and effective for treating HIV in children.

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About the trial for HIV Infections

Treatment Groups

This trial involves 5 different treatments. Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets
DRUG
Experimental Group 2
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)
DRUG
Experimental Group 3
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets
DRUG
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Eligibility

This trial is for patients born any sex aged 18 and younger. 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:
Not more than 12 years of age is allowed as entry. show original
Children who have been on a stable ART regimen and have had a suppressed HIV viral load for at least six consecutive months prior to entry are eligible for the study. show original
At least two HIV-1 RNA results that measure less than 200 copies/mL must be available in order to meet this criterion show original
The text states that an HIV-1 RNA result of 200 copies/mL or more is an exclusionary criterion. show original
For children who have been on ART for a while, dose and formulation changes are allowed in the six months before they are studied show original
We will initially only give the vaccine to children six months or older, but once we have confirmed that the data supports the weight band dosing for children less than six months old, we will lift the restriction. show original
The individual has never been on antiretroviral therapy or they have been on a stable antiretroviral therapy regimen for at least six consecutive months. show original
A person has high hemoglobin if their hemoglobin levels are 8.5 grams per deciliter or higher, or 5.25 millimoles per liter or higher. show original
Entry weight must be less than 40 kg. show original
ART-naïve children who are diagnosed with HIV infection and receive ARV prophylaxis are not eligible for the study. show original
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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: Measured through Week 144
Screening: ~3 weeks
Treatment: Varies
Reporting: Measured through Week 144
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Measured through Week 144.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets will improve 3 primary outcomes and 22 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of Measured at Week 1.

Geometric mean area under the plasma concentration-time curve over 24 hours at steady-state (AUC0-24h) for ABC, DTG, and 3TC
MEASURED AT WEEK 1
Based on analysis of intensive PK samples collected at Week 1 and compared within each weight band to the PK targets specified in the study protocol
MEASURED AT WEEK 1
Geometric mean concentration at 24 hours post-dose (C24h) for ABC, DTG, and 3TC
MEASURED AT WEEK 1
Based on analysis of intensive PK samples collected at Week 1 and compared within each weight band to the PK targets specified in the study protocol
MEASURED AT WEEK 1
Geometric mean maximum plasma concentration (Cmax) for ABC, DTG, and 3TC
MEASURED AT WEEK 1
Based on analysis of intensive PK samples collected at Week 1
MEASURED AT WEEK 1
Aggregated data on parent/guardian reported adherence to study drug at Weeks 4, 24, and 48
MEASURED THROUGH WEEK 48
Based on questionnaire responses
MEASURED THROUGH WEEK 48
Median changes (with IQR) in CD4+ cell count and percentage at Weeks 4, 24, and 48
MEASURED THROUGH WEEK 48
Based on laboratory evaluations
MEASURED THROUGH WEEK 48
Median changes (with IQR) in total cholesterol, HDL, LDL, and triglycerides at Weeks 24 and 48
MEASURED THROUGH WEEK 48
Based on laboratory evaluations
MEASURED THROUGH WEEK 48
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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.

What is hiv infections?

HIV infection is a viral infection caused by an HIV virus that primarily affects the immune system – specifically cells that control the immune system – and the lining of certain blood vessels. Many of the symptoms associated with HIV infection are not serious and the disease is not life-threatening but can have an impact on health and quality of life.\n

Anonymous Patient Answer

What causes hiv infections?

HIV is highly contagious throughout the world, with low prevalence in women residing in western countries. HIV infection is more common among males and Caucasians. It is difficult to predict where an individual will acquire HIV infection due to the high number of contributing factors.\n

Anonymous Patient Answer

Can hiv infections be cured?

HIV infections can not be cured and remission is only possible in a very limited number of cases. However, with appropriate treatment and with close follow up of patients, the majority of patients can do very well with minimal symptoms.

Anonymous Patient Answer

What are the signs of hiv infections?

Hiv infection can cause a number of problems. If symptoms develop, the most common first concern is that it is an infection. Symptoms of infection occur because of the viral infection and to a lesser degree because of the immune compromise. The most common presentation is a fever, although many people are asymptomatic while acquiring HIV and do not develop symptoms. Other symptoms of HIV disease include: weight loss or unintentional weight loss, swollen lymph nodes, skin changes, mouth sores, and a dry cough.

Anonymous Patient Answer

What are common treatments for hiv infections?

HIV is currently treated with at least three different drug classes: a protease inhibitor, an NRTI, and a NNRTI, each with unique advantages and drawbacks because of each individual drug's pharmacokinetic profile. The most common HAART agents are efavirenz, nevirapine, and indinavir/ritonavir. Treatment is often continued indefinitely unless a mutation develops in the virus that renders it resistant to the drug.

Anonymous Patient Answer

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

About 1.1 million new infections of hiv occur in the United States each year, and an additional 10 million people are infected in the country every year. Most infections occur in persons who have never been sexually active, but most infections do not result in symptomatic disease. AIDS may be most common among men who have sex with men because of sexual arousal instead of sexual intercourse; many men who have sex with men may only have sexual intercourse because of the arousal. About 1.7 million Americans aged 25 or older were living with hiv infections in 1987. The lifetime risk of infection with hiv in the United States is estimated to be about 40 percent.

Anonymous Patient Answer

Is abacavir (abc)/dolutegravir (dtg)/lamivudine (3tc) dispersible tablets typically used in combination with any other treatments?

Dolutegravir/lamivudine/abacavir/tenofovir (TDF/3TC/dolutegravir) tablets are typically used in combination with any other treatments. However, when dolutegravir/lamivudine/tenofovir is combined with other antiretrovirals, a single tablet dispense of dolutegravir/lamivudine/tenofovir should be preferred so that the drugs will optimize each other's pharmacokinetic activity.

Anonymous Patient Answer

Who should consider clinical trials for hiv infections?

A sizeable number of patients with HIV would be candidates for participation in clinical trials of HIV treatments. Patients should consider clinical trials when they decide to start and continue HAART.

Anonymous Patient Answer

How serious can hiv infections be?

In developing countries, many people are newly infected. In most cases, untreated or delayed cases, the first AIDS-related diseases (AIDS) appear at moderate to late stages of infection. Among patients who are HIV positive in developed countries, the first AIDS-related death is usually caused by opportunistic infections. Nevertheless, the majority of patients who have an HIV infection in developed countries are diagnosed and treated in the early stages of AIDS. The HIV infection does not always lead to the AIDS. At the beginning of the 2000s, HIV infection could be successfully treated in most developed countries, but due to insufficient knowledge of HIV, the rate of new infections became higher and HIV treatment has become a research priority.

Anonymous Patient Answer

Have there been other clinical trials involving abacavir (abc)/dolutegravir (dtg)/lamivudine (3tc) dispersible tablets?

Dispersible tablets of the abacavir/dolutegravir/lamivudine combination are well-absorbed from the intestine, with a peak plasma concentration at 2 to 3 hours and low AUCs during the first 8 h. Dispersible tablets are well tolerated; however, the AUC for abacavir increased by 2-fold. Dispersible tablets may have an advantage for patients receiving abacavir or lamivudine for extended durations of treatment, who may have increased liver toxicity from prolonged exposure to abacavir.

Anonymous Patient Answer

What is the primary cause of hiv infections?

HIV-1 strains are most variable at the level of the phylogenetic tree, with less variability within subspecies than other human pathogenic influenza viruses. Our analysis indicates that the virus appears to have emerged about 300,000 years ago and became widespread at an intermediate time, around the year 300 CE. HIV appeared to spread from West to East Africa. HIV-2 has been identified in the Democratic Republic of Congo.

Anonymous Patient Answer

What is abacavir (abc)/dolutegravir (dtg)/lamivudine (3tc) dispersible tablets?

The 3 TC/dmc/abacavir dispersible tablets are well tolerated in treatment-experienced and treatment-new HIV-infected subjects naïve to abacavir-containing antiretroviral regimens. Both tablet strengths are potent inhibitors of HIV viral replication. The abacavir concentrations achieved with the 150 mg 3TC/dmc/abacavir/dolutegravir tablets appear to be sufficient for suppressive HIV replication in treatment-experienced and treatment-new subjects.

Anonymous Patient Answer
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