ATV for HIV Infections

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
HIV-NAT, Bangkok, Thailand
HIV Infections+3 More
ATV - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants

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Eligible Conditions

  • HIV Infections
  • Acquired Immune Deficiency Syndrome (AIDS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for HIV Infections

Study Objectives

This trial is evaluating whether ATV will improve 3 primary outcomes and 13 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of Week 24.

Week 4
Acceptability of COBI and F/TAF as Measured by Palatability
Week 24
Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Treatment Emergent Laboratory Abnormalities Through Week 24
Week 12
PK Parameter: CL/F of ATV, DRV, and TAF for Cohorts 2 and 3
PK Parameter: Cmax of ATV, DRV, COBI, TAF, FTC and TFV for Cohorts 2 and 3
PK Parameter: Ctau of ATV, DRV, COBI, FTC, and TFV for Cohorts 2 and 3
PK Parameter: Vz/F of COBI and TAF for Cohorts 2 and 3
Week 12
PK Parameter: CL/F of ATV, DRV, and COBI for Cohort 1
PK Parameter: Cmax of ATV, DRV, and COBI for Cohort 1
PK Parameter: Ctau of ATV, DRV, and COBI for Cohort 1
PK Parameter: Vz/F of COBI for Cohort 1
Week 4
Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, and TAF for Cohorts 2 and 3
Day 10
Pharmacokinetic (PK) Parameter: AUCtau of ATV and DRV
Week 48
The incidence of treatment-emergent AEs and treatment-emergent laboratory abnormalities through Week 48
Week 24
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 and as defined by the US FDA-defined snapshot algorithm
Week 48
The change from baseline in CD4+ cell counts
The change from baseline in CD4+ percentages

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for HIV Infections

Trial Design

4 Treatment Groups

Cohort 2
1 of 4
Part A, Cohort 1
1 of 4
Cohort 3
1 of 4
Part B, Cohort 1
1 of 4
Experimental Treatment

This trial requires 100 total participants across 4 different treatment groups

This trial involves 4 different treatments. ATV is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Cohort 2Participants ages 6 to <12 years old will receive cobicistat 150 mg and emtricitabine/tenofovir alafenamide 200/25 mg with either ATV or DRV.
Part A, Cohort 1Participants ages 12 to <18 years old will receive cobicistat 150 mg with either ATV or DRV plus BR. The BR may contain additional antiretroviral agents except for the following disallowed agents: saquinavir, indinavir, nelfinavir, double protease inhibitor (PI) regimens, raltegravir, elvitegravir, efavirenz, nevirapine, delavirdine, maraviroc, etravirine, rilpivirine, dolutegravir, and investigational antiretroviral agents.
Cohort 3Participants ages ≥ 3 will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV.
Part B, Cohort 1Participants ages 12 to <18 years old will receive cobicistat 150 mg with either ATV or DRV plus BR. The BR may contain additional antiretroviral agents except for the following disallowed agents: saquinavir, indinavir, nelfinavir, double protease inhibitor (PI) regimens, raltegravir, elvitegravir, efavirenz, nevirapine, delavirdine, maraviroc, etravirine, rilpivirine, dolutegravir, and investigational antiretroviral agents.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darunavir
FDA approved
Cobicistat
FDA approved
Atazanavir
FDA approved
BR
2009
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: intensive pk samples at predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at week 2 or week 4. trough pk samples at weeks 8, 24, and 36, and timed pk samples (15 minutes to 3 hours post-dose) at weeks 12, 16, and 48
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly intensive pk samples at predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at week 2 or week 4. trough pk samples at weeks 8, 24, and 36, and timed pk samples (15 minutes to 3 hours post-dose) at weeks 12, 16, and 48 for reporting.

Closest Location

University of South Florida - Tampa, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
HIV-1 infected treatment-experienced, virologically suppressed males and females aged 3 years to < 18 years at the Day 1 visit (according to requirements of enrolling Cohort)
Body weight at screening ≥ 25 kg (Cohorts 1), 14 kg to < 25 kg (Cohort 3)
Stable antiretroviral regimen including 2 nucleoside reverse transcriptase inhibitors and either ritonavir-boosted atazanavir or ritonavir-boosted darunavir once or twice daily as per product label for a minimum of 3 months prior to the screening visit. Treatment-experienced pediatric individuals taking DRV/r must have no history of DRV resistance associated mutations.
Documented negative screening for active pulmonary tuberculosis (TB) per local standard of care within 6 months of a screening visit
Note: Other protocol defined Inclusion/

Patient Q&A Section

What causes hiv infections?

"Sexual intercourse without use of HIV-prevention methods is the single most important risk factor for HIV in men. As condoms protect against some sexually transmitted diseases they also protect against HIV, but only about half of men on PrEP use them, and condom use may not be enough. Other strategies or combinations of strategies are needed to prevent the majority of new HIV infections in sub-Saharan Africa." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hiv infections?

"This section covers medications approved for HIV infections. While no definitive treatment can be guaranteed, the use of ART generally improves overall health and promotes and sustains remission." - Anonymous Online Contributor

Unverified Answer

Can hiv infections be cured?

"This review of the literature suggests that there exist viable treatments for HIV infections after treatment discontinuation and is supportive, at least in principle, of the concept of HIV remission. The evidence base consists of one small trial with a possible selection bias in which only 20% of the trial subjects enrolled are eligible to be in the study. There is no high-quality evidence relating to cure. The trials also all contain significant limitations and it is possible that remission rates were overestimated or underestimated in the studies reviewed here. Clearly, more effective treatments for HIV infection are urgently needed. Although anecdotal cures may be found among select groups of patients, the current knowledge does not support claims that it can be cured or eliminated. Therefore, these conclusions must be interpreted with caution." - Anonymous Online Contributor

Unverified Answer

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

"There are approximately 700,000 new cases of HIV infection each year in the United States. This makes it the most common infectious disease in the United States." - Anonymous Online Contributor

Unverified Answer

What is hiv infections?

"HIV infections are caused by two types of viruses, the single-stranded, positive-sense, HIV-1 and HIV-2 viruses. Many types of HIV-1 and HIV-2 can be spread to others by unprotected sexual intercourse. HIV infections may also be transmitted via blood transfusions. HIV infection is an infection or diseases caused by the infection of HIV-1 and HIV-2. The World Health Organization (WHO) estimated that the number of people infected by HIV/AIDS in 2010 was about 35 million people. The total number of people living with HIV/AIDS worldwide is about 25 million. HIV/AIDS can result in death within a year of infection." - Anonymous Online Contributor

Unverified Answer

What are the signs of hiv infections?

"HIV infection can be suspected when a patient is febrile and positive for antibodies to the virus, but the symptoms are nonspecific and do not reliably implicate the virus. As a result, clinicians should be cautious about excluding other forms of febrile illness of presumed viral etiology, so they can more reliably rule out other causes of fever." - Anonymous Online Contributor

Unverified Answer

How does atv work?

"It is unclear how the use of atv can be recommended. Whilst there is some evidence of potential benefit in patients with HIV-associated neurocognitive disorder, the quality of the currently available trials is poor, and the evidence for benefit was inconsistent and of poor quality. The studies available do not provide good data for the initiation of treatment with atv. In addition, it is difficult to draw generalisable conclusions about the safety and effects of atv in patients with HIV. Therefore, in routine clinical practice it is not yet possible to determine if there is an indication for atv therapy." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hiv infections?

"HIV-1 strains from our patients fall into four distinct lineages of HIV-1 epidemics: subtype B/HIV-1 (95% of individuals infected with HIV-1) and subtype A/HIV-1 (4% of individuals infected with HIV-1), as well as subtypes F/HIV-1 and A/HIV-1 (4% of individuals infected with HIV-1) lineages. To the best of our knowledge, this is the first analysis documenting the genetic heterogeneity of HIV-1 infection dynamics." - Anonymous Online Contributor

Unverified Answer

Has atv proven to be more effective than a placebo?

"Atv appeared to be as effective as a placebo when prescribed for the treatment of HIV-associated dementia or HIV-associated dementia with psychosis. Larger studies would be desirable to confirm our findings." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hiv infections?

"Based on the overall data available, the most commonly used assumption is that persons do get hiv infections at a median age of 19 years (with a 95% confidence interval at ages 18 and 23) in developed countries. However, it is possible that persons who are at increased risk of getting hiv do so at younger age, and that [the distribution of age of hiv infections is unimodal and skewed towards young ages] (see Figure)." - Anonymous Online Contributor

Unverified Answer

How serious can hiv infections be?

"HIV infections are common but often underrecognized. They account for more morbidity, mortality and costs than previously thought, so prompt diagnosis, treatment and the promotion of timely CD4 monitoring is paramount to improving outcomes. Effective use of standard care is essential in reducing morbidity and mortality and in increasing the chance of achieving a successful HIV outcome." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hiv infections?

"It seems that the treatments that were used in the past are becoming less effective or ineffective because the virus tends to become resistant more and more fast. Since HIV and its virus have been known for more than 20 years, it is time to [find out a better way to treat HIV infections; in other words, the [new HIV treatments]] that will be effective or most effective and [have fewer adverse effects]." - 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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