Islatravir for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Clinical HIV Research Unit CHRU ( Site 0014), Johannesburg, South Africa
Human Immunodeficiency Virus Type 1 (HIV-1) Infection+2 More
Islatravir - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called islatravir is safe and well tolerated.

See full description

Eligible Conditions

  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Islatravir will improve 8 primary outcomes and 11 secondary outcomes in patients with Human Immunodeficiency Virus Type 1 (HIV-1) Infection. Measurement will happen over the course of Up to week 20.

Week 20
Apparent terminal half-life of plasma islatravir
Area under the concentration-time curve of plasma islatravir
Maximum concentration of plasma islatravir
Trough concentration of plasma islatravir
Up to Week 68
Participants with a Grade 3 to 5 AE
Participants with a Grade 3 to 5 and drug-related AE
Participants with a drug-related AE
Participants with a serious adverse event
Participants with a serious and drug-related AE
Participants with an AE resulting in death
Participants with an adverse event
Up to week 20
Participants who discontinued from study therapy
Up to week 24
Participants with Grade 3 to 5 AE up to week 24
Participants with Grade 3 to 5 and drug-related AE up to week 24
Participants with a SAE up to week 24
Participants with a drug-related AE up to week 24
Participants with a serious and drug-related AE up to week 24
Participants with an AE resulting in death up to week 24
Participants with an AE up to week 24

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

Islatravir 120 mg
1 of 3
Islatravir 60 mg
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 242 total participants across 3 different treatment groups

This trial involves 3 different treatments. Islatravir is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Islatravir 120 mg
Drug
120 mg islatravir administered once monthly, orally in capsule form for 24 weeks
Islatravir 60 mg60 mg islatravir + placebo for islatravir administered once monthly, orally in capsule form for 24 weeks
Placebo
Drug
Placebo for islatravir administered once monthly, orally in capsule form for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Islatravir
Not yet FDA approved
Placebo
1995
Completed Phase 3
~2810

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 and week 20, collect predose and 30-min postdose. on day 2 collect ~24 hours after day 1 dose. on weeks 4, 8, 12 and 16, collect predose. weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 1 and week 20, collect predose and 30-min postdose. on day 2 collect ~24 hours after day 1 dose. on weeks 4, 8, 12 and 16, collect predose. weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit. for reporting.

Closest Location

Magee Womens Research Institute ( Site 0001) - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Is in general good health with acceptable laboratory values at screening
Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
Has low risk of HIV infection, within 12 months prior to screening visit or the rescreening visit (if applicable)
Use contraceptives consistent with local regulations
Female is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP)
A WOCBP is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; or has a negative pregnancy test.

Patient Q&A Section

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

"Approximately 4.5 million people a year get a prescription for an infectious illness, or become a patient with an infection while awaiting a diagnostic test. These may include acute illnesses such as upper respiratory infections and bacterial pneumonia. Other common illnesses such as viral disorders, chronic illnesses, and medication-induced infections account for approximately 6.1% of antibiotic prescriptions each year. Over 20.6 million a year get prescriptions for other medications used to treat infections. These include antimicrobial agents and non-steroidal compounds designed to treat these conditions. It is estimated that nearly 1.3 million are hospitalized for an infection during a given year." - Anonymous Online Contributor

Unverified Answer

What are the signs of infections?

"Infections have a characteristic appearance that can be detected by the presence of unexplained fevers, unexplained fevers, or unexplained cough. Other signs of infections can include a dulled sense of hearing. Also, a fast heart rate can be an early sign of infection." - Anonymous Online Contributor

Unverified Answer

What is infections?

"Infections can be caused by viruses, bacteria and parasites. The viruses that can be transmitted to the foetus can cause miscarriage or fetal death, and HIV and many other viruses can also be transmitted during childbirth. Bacteria can be found in the food you eat, in the water where you swim or by contacting your skin or touching objects that contaminated by bacteria. Parasites that cause diarrhoea and blood infections are transmitted through the faeces and urine of animals." - Anonymous Online Contributor

Unverified Answer

What causes infections?

"There is a wide variety of viruses that can cause infections, including viruses that cause infections by directly affecting the nervous system. Viral infections can result in encephalitis or encephalomyelitis. Most viral encephalitis cases are caused by influenza or enteroviruses, either alone or in combination. Other herpesviruses can cause encephalitis, and these include herpes simplex viruses, varicella, and cytomegalovirus. Certain protozoa cause infections that result in encephalitis by causing infection of the central nervous system. These include Cryptosporidium, Toxoplasma, and histoplasma. Other parasites can cause encephalitic infections." - Anonymous Online Contributor

Unverified Answer

Can infections be cured?

"The current and recent evidence for curing infections is mostly speculative, based upon limited studies of poor quality. For example, if an infection-related maladaptation is the cause, curing it should lead to normal immune function. However, in many cases, causality is yet to be established and treatment is based on opinion rather than empirical evidence. For a subset of diseases (such as tuberculosis), treatments are not based on this approach and are effective." - Anonymous Online Contributor

Unverified Answer

What are common treatments for infections?

"The common treatments of infections often overlap with those of the corresponding diagnoses. There are few, if any, specific medications that can be used as monotherapy against most infections. Most antibiotics are effective against bacterial diseases, and are also effective against certain protozoal, viral, and fungal infections. Most drugs are also effective against parasites and will work against certain protozoal, fungal, or protozoan infections if taken correctly. Antimycotics are effective against yeasts and fungi. Antineoplastic agents work against both hematologic malignancies and some other cancers. Drugs that specifically target the central nervous system are also effective against some infections." - Anonymous Online Contributor

Unverified Answer

How serious can infections be?

"There are a huge number of infections and the vast majority of them can be treated. The most common, nonprogressive infections, are the most common: [influenza](https://www.withpower.com/clinical-trials/influenza) and bronchitis. There are serious, life-threatening complications. Serious ones are more likely to occur in hospitalizations than at home or at the general practitioner's office. Serious complications include peritonitis, pneumonia, sepsis, cellulitis, acute pancreatitis and a rare complication called "Legionella," which has a high mortality rate and is more likely to occur in hospital patients than at home or the general practitioner's office. Infections are more likely to occur during a short time period: at the end of winter and early spring (the flu season)." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of islatravir?

"While islatravir, a triple drug HIV drug, is relatively well tolerated, about one-third of patients reported at least one common side effect. Although some side effects are not common to HIV antiretrovirals in general, some of the side effects encountered with islatravir are in fact reported with others." - Anonymous Online Contributor

Unverified Answer

What is islatravir?

"A single tablet regimen of 160 mg islatravir was tolerated well by patients. Most patients had measurable serum levels of islatravir and demonstrated antiviral activity. The treatment regimens investigated were not associated with a reduction in the incidence of HIV-1 DNA shedding, however there is no data on the effects of prolonged exposure to islatravir on long term HIV-1 transmission in vivo." - Anonymous Online Contributor

Unverified Answer

What is the latest research for infections?

"This month's research covers the antibiotic-resistant bacterial infections that can devastate the body. There is also information about the way the body tries to fight infections in the last few seconds. This month's issue can help keep you informed for the rest of the year." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of infections?

"Patients with the most [severe] infections had a history of a previous, underlying medical condition most often a [major|major medical disease/injury]. The number of infections increased with age, and infections tended to be multiple, or multiple, and severe and frequently prolonged. Infections were most often seen after immunizations, and were most often seen by a [doctor] [health care provider] and not a [health care provider]. There [had been] prior antibiotic exposure. However, the main cause was not determined and [was] not seen as an [action] the [primary] [cause] of the [primary] [disease]. (Primary and secondary causes of infections." - Anonymous Online Contributor

Unverified Answer

What does islatravir usually treat?

"Islatravir is not usually used for the treatment of HIV-1 infection by itself. Given its favorable safety profile and its potential usefulness in combination therapy for HIV-infected individuals who have an HCV-associated infection and may benefit from combination treatment for this." - 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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