ABC/DTG/3TC immediate release tablets for HIV Infections

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
GSK Investigational Site, Moshi, Tanzania
HIV Infections
ABC/DTG/3TC immediate release tablets - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of drugs may help treat HIV.

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Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether ABC/DTG/3TC immediate release tablets will improve 1 primary outcome and 3 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of Up to 2 years.

Up to 2 years
Number of participants with SAEs based on the severity
Number of participants with any clinical or laboratory adverse events leading to discontinuation of investigational product
Number of participants with serious adverse events (SAEs) as a measure of safety
Up to 4 years
Number of participants with continued access to age appropriate formulation of dolutegravir

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Dolutegravir (Tivicay)
1 of 2
ABC/DTG/3TC
1 of 2
Experimental Treatment

This trial requires 300 total participants across 2 different treatment groups

This trial involves 2 different treatments. ABC/DTG/3TC Immediate Release Tablets is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Dolutegravir (Tivicay)All participants will receive dolutegravir film-coated tablets or film-coated dispersible tablets at appropriate doses selected as per their age and weight bands. For those participants who were previously receiving dolutegravir in study P1093 (parent study), dolutegravir will be supplied as film-coated tablets containing 10 milligram (mg), 25 mg and 50 mg; and 5 mg film-coated dispersible tablets of dolutegravir. Participants will receive dolutegravir until age-appropriate formulations are available to them from some other source, or until participant is no longer deriving benefit from treatment, or participant is discontinued, or until development of dolutegravir is terminated. The dose adjustment will be made if a participant's weight change requires a dose adjustment.
ABC/DTG/3TCAll participants will receive ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets at appropriate doses selected as per their weight bands. For those participants who were previously receiving ABC/DTG/3TC in study P2019 (parent study), ABC/DTG/3TC will be supplied as immediate release tablets containing 600 mg, 50 mg and 300 mg of ABC, DTG, and 3TC respectively and film-coated dispersible tablets containing 60 mg, 5 mg and 30 mg of ABC, DTG, and 3TC respectively. Participants will receive ABC/DTG/3TC until age-appropriate formulations are available to them from some other source, until participant is no longer deriving benefit from treatment, or until participant is discontinued, or until development of ABC/DTG/3TC is terminated. The dose adjustment will be made if a participant's weight change requires a dose adjustment.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 4 years for reporting.

Closest Location

GSK Investigational Site - Memphis, TN

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participant must have completed participation in one of the following parent studies, for the duration noted, with continued benefit from investigational product: a. P1093 parent study through at least Week 180; b. P2019 parent study through at least Week 48. Participant with evidence of Virological Failure in either parent study must have eligibility for this rollover study discussed and agreed with the ViiV Healthcare Medical Monitor.
Virological control: a. Participants in parent study P1093 must have virological control defined as HIV-1 ribonucleic acid (RNA) <400 copies per milliliter (c/mL) at their penultimate visit (on or after the Week 180 visit); b. Participants in parent study P2019 must have virological control defined as HIV-1 RNA <200 c/mL at their penultimate visit (on or after Week 36).
Males and Females: All participants who are engaging in sexual activity should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (example [e.g.] male condom) and on the risk of HIV transmission to an uninfected partner. Females: Female participants who are of child bearing potential and who are engaging in sexual activity that could lead to pregnancy, must agree to use one of the acceptable birth control methods until the last dose of study medication and completion of the follow-up visit (4 weeks after the last dose). Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.
Parent or legal guardian or participant >=18 years of age is able and willing to provide signed informed consent.

Patient Q&A Section

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

"About 1 million new HIV infections are estimated to occur each year in the US, representing about 20% of those living with HIV. The number of new infections is likely to continue increasing; if so, this may threaten to undermine the US effort to control HIV." - Anonymous Online Contributor

Unverified Answer

What causes hiv infections?

"The route of HIV transmission depends partly on the sexual behavior of those entering a high risk setting, with higher rates of transmission occurring with unprotected anal sex. The HIV epidemic is due to the spread of this virus through heterosexual transmission, with men involved in the sexual behaviors associated with HIV transmission. However, there is increasing evidence of an epidemic of AIDS, especially in the United States, and it will be necessary to devise a new approach to preventing HIV infection. The risk of transmission decreases when condom use is practiced regularly. This is especially true for men who have sex with men. The sexual practices of men who have sex with men are a major cause for the epidemic in Africa. Male homosexual behavior is associated with an increased risk for contracting HIV." - Anonymous Online Contributor

Unverified Answer

Can hiv infections be cured?

"Even with advanced and prolonged HIV infection, antiviral combination HIV therapy is able to eradicate HIV infection, as determined by two- to threefold declines of the HIV RNA. Although this cure is always symptomatic, it is generally clinically effective." - Anonymous Online Contributor

Unverified Answer

What is hiv infections?

"There is no single infection/disease that causes AIDS. Many conditions affect people with HIV, such as malnutrition, opportunistic infections or chronic illnesses, and the disease itself is also known by other infectious diseases transmitted by HIV. HIV and AIDS are caused by a virus that is spread by sexual contact, blood, and breastfeeding. HIV is transmitted when a person has genital fluid or mucous membranes of another person who is HIV-positive. The average person acquires HIV orally by touching a surface (such as a pillowcase or glass), or by sharing an object (for example, a needle) that is contaminated with mucosal fluid." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hiv infections?

"Antiretroviral drugs are the primary treatment for most HIV infections. Many HIV patients also get antimalarial drugs and antifungals. Antihistamines and anxiolytics are used for migraines and depression respectively. Hormonal therapy is used to treat prostate cancer and hirsutism. Antihypertensives are administered to treat high blood pressure. Anti-obesity drugs are used to treat obesity. Antidiabetic medication is used to treat diabetes mellitus, fatty liver disease and elevated serum cholesterol. Prohormones may be used to treat estrogen deficiency in elderly women with decreased bone mineral density." - Anonymous Online Contributor

Unverified Answer

What are the signs of hiv infections?

"HIV infections have been identified as a major non-communicable disease in Uganda. HIV positive individuals have high rates of respiratory and digestive infections. Other features of HIV infections include increased risk of lymphoma, Kaposi sarcoma, and other cancers. HIV-1 infection is the most common form of HIV in Uganda but a variety of viral species may also contribute. The signs and symptoms of HIV infections are due to the viral pathogens themselves and not in direct proportion to HIV virus load or immune status. The main clinical signs of HIV infections are swelling in the genital and rectal (esophagus) mucosal tissues and of the liver and adrenal glands. Signs of opportunistic infections may include unexplained fevers and weight loss." - Anonymous Online Contributor

Unverified Answer

What is abc/dtg/3tc immediate release tablets?

"The abc/ddtg immediate release tablets may be a good choice in developing countries where healthcare is expensive and where some health workers have to take long walks to get medications. For industrialized countries, they may also be a reasonable option. However, the current abc/ddtg immediate release tablets do not have the durability and quality of the brand name medication. The manufacturer can make additional improvements to the pills. One might take the pills exactly the same way every day, while others might make adjustments to the dosing frequency that will improve the cost-effectiveness." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hiv infections?

"Only two new medications have been approved for treating the hiv virus, AZT (zidovudine) and lamivudine. Both of these medications are associated with significant side effects and are typically used only when other therapies are insufficient." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving abc/dtg/3tc immediate release tablets?

"There are many types of antiretroviral therapies, and there are multiple ways of packaging abc/dtg/3tc immediate release tablets. Current FDA-approved antiretroviral medicines are not interchangeable, but other ways of packaging abc/dtg/3tc immediate release tablets might be available." - Anonymous Online Contributor

Unverified Answer

Does abc/dtg/3tc immediate release tablets improve quality of life for those with hiv infections?

"Overall, it appears that abc/dtg/3tc has only a small effect on quality of life scores, especially among those without other treatment challenges. These data are reassuring given concerns regarding abc/dtg/3tc's potential to increase HIV transmission in resource-poor countries that already have high rates of HIV transmission." - Anonymous Online Contributor

Unverified Answer

Is abc/dtg/3tc immediate release tablets typically used in combination with any other treatments?

"Recent findings shows a variety of abc/dtg/3tc treatment regimens with various combinations of other antiretroviral drugs. The authors hope that this information will aid clinicians in prescribing the most appropriate abc/dtg/3tc tablet combination for their individual patients." - Anonymous Online Contributor

Unverified Answer

Has abc/dtg/3tc immediate release tablets proven to be more effective than a placebo?

"Although more participants in the abc/dtg immediate release tablet group reported feeling better after dosing compared with placebo, the two groups' mean scores did not differ after treatment. Thus, it is unclear whether abc/dtg immediate release tablets were more effective overall than placebo for HIV-related symptoms or not at all." - Anonymous Online Contributor

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