Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets for HIV Infections
This study is evaluating whether a combination of drugs may be safe and effective for treating HIV in children.
See full descriptionAbout 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.
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.
Approximate Timelines
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.
Patient Q & A Section
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.