CLINICAL TRIAL

Maraviroc for HIV Infections

Waitlist Available · < 65 · All Sexes · Wilmington, DE

This study is evaluating whether a drug called maraviroc can be used to treat HIV in children and adolescents.

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About the trial for HIV Infections

Eligible Conditions
Acquired Immunodeficiency Syndrome · Human Immunodeficiency Virus (HIV) Infections · HIV Infections

Treatment Groups

This trial involves 2 different treatments. Maraviroc is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Maraviroc
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Maraviroc
FDA approved

Side Effect Profile for Maraviroc

Maraviroc
Show all side effects
Somnolence
6%
Constipation
6%
Peripheral neurophathy
6%
Folliculitis
6%
Dyspepsia
0%
Back pain
0%
Headache
0%
This histogram enumerates side effects from a completed 2008 Phase 4 trial (NCT00666705) in the Maraviroc ARM group. Side effects include: Somnolence with 6%, Constipation with 6%, Peripheral neurophathy with 6%, Folliculitis with 6%, Dyspepsia with 0%.

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subjects who are 2-18 years of age, treatment experienced for 6 months or longer with at least 2 ARV drug classes, with HIV-1 RNA ≥1,000 copies/mL
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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: Baseline up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline up to 5 years.
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Maraviroc will improve 5 primary outcomes and 14 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of Screening to Week 48.

Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48
SCREENING TO WEEK 48
Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. Change in detected tropism from screening to the time of failure prior to Week 48 was reported. X4=CXCR4 tropic virus; R5=CCR5-tropic virus; X4=CXCR4-tropic virus. Number of participants as per tropism to respective virus has been reported.
Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF
48 WEEKS
Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Data for participants with respective gene mutation category has been reported. Participants with more than one mutation are counted more than once.
Percentage of Participants With Optimized Background Treatment Susceptibility Scores
48 WEEKS
Data was summarized by the total ARV activity of the background regimen using simple and weighted total optimized background treatment susceptibility scores as well as by screening genotype. Simple total optimized background treatment (OBT) susceptibility scores were categorized as 0, 1, >=2 and weighted total OBT susceptibility scores were categorized as 0 to 0.5, 1 to 1.5 and >=2. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores ranged from 0 to 1 as 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance, where higher scores indicated lower resistance.
Number of Participants With Protocol Defined Virologic Failure
WEEK 48
The occurrence of any one of the following criteria would constitute Virologic failure: Criteria A=Decrease from Baseline plasma HIV-1 RNA <1 log10 and plasma HIV-1 RNA >400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; Criteria B=Decrease from Baseline plasma HIV-1 RNA <2.0 log10 and plasma HIV-1 RNA >400 copies/mL at Week 24 OR plasma HIV-1 RNA >10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; Criteria C=Increase from nadir plasma HIV-1 RNA of >=1 log10 (>=1,000 copies/mL if nadir plasma HIV-1 RNA <48 copies/mL) at any time, and confirmed within 14 to 21 days.
Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48
WEEK 48
TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.
Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48
BASELINE, WEEK 24 AND WEEK 48 POST-TREATMENT
Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.
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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 are the signs of hiv infections?

In men with syphilis, a non-painful, diffuse, movable painless swelling of the penis is commonly described. In asymptomatic HIV-infected men, urethritis can often be mistaken for reactive arthritis, but urethral findings can include a chancre-like appearance. The detection of Papanicolaou smears in an uncircumcised prepuce, specifically, is not a definitive indication that the patient has an HIV infection.

Anonymous Patient Answer

Can hiv infections be cured?

As HIV treatment is becoming more effective, it is increasingly important to assess curability. Using hiv as curability has its limitations, although curable rates have risen from 12% in 1996 to 32% today. The cure rate depends on many factors, including viral mutation in individuals, selection of initial treatment, adherence, duration of treatment, and, in some cases, the presence of a co-infectious viral infection. The chances of cure are especially low if you have active HIV. It is difficult to predict when an HIV infection will progress into AIDS, when it will become incurable, or when treatment will lead to long-term remission.

Anonymous Patient Answer

What is hiv infections?

HIV is an infection which can result in a HIV related illness or disability, and has major economical and social implications. The most common form of HIV in Europe and the USA is HIV-1, transmitted from a person to a person through close contact. HIV-2 is endemic in Western Africa. Transmission of HIV is mostly through sexual activity, through infected needles or blood transfusions. HIV infections are not curable, can be controlled by medication, and a cure has not yet been discovered. AIDS is a chronic and often life threatening illness related to HIV/AIDS that does not discriminate between sexes and can even cause infertility, which is why people often do not find out they are infected.

Anonymous Patient Answer

What are common treatments for hiv infections?

People with HIV are often prescribed several medications to treat a variety of unrelated conditions. Few (20%) of the medication used were related to the HIV infection. The most common treatment for HIV positivity was HAART, while HAART was often used off-label as a first-line regimen for treatment in combination with other antiretroviral agents.

Anonymous Patient Answer

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

HIV infections in the United States have increased dramatically. The CDC needs to increase its surveillance of HIV infections in order to better understand the current trends of HIV infections, its consequences, and its potential treatment.

Anonymous Patient Answer

What causes hiv infections?

HIV can be contracted by sexual intercourse (up to 25%), through exposure to infected blood (up to 10% per exposure), through contamination by body fluid (up to 5% per exposure) or through blood transfusions (up to 1% per exposure). While HIV is not spread by coughing, it spread through contact with skin ulcers. Sexual practices such as oral sex (up to 50% of cases) and frotting (up to 5%) are associated with HIV. While condoms do not eradicate HIV it can prevent and reduce the transmission of the virus through sexual intercourse.

Anonymous Patient Answer

Does hiv infections run in families?

The findings demonstrated that risk for HIV infection was associated with low socioeconomic status, early age of onset of sexual activity, and number of previous sexual partners. The association between parental HIV-positive status and increased risk of offspring HIV-positive status were also found. In view of its relatively low prevalence, it seems unlikely that HIV is a true "family disease.

Anonymous Patient Answer

How does maraviroc work?

Maraviroc's effects on HIV-1 infection, and its potential use in prevention and treatment, emphasize the importance of HIV-1 dynamics and how they are regulated by drug manipulation of reverse transcription and viral replication. These studies show the importance of drug selection by cell type and drug concentration, as well as the complexity of HIV-1 infection.

Anonymous Patient Answer

Does maraviroc improve quality of life for those with hiv infections?

Most patients with HIV/HCV coinfections had good global and physical quality of life, regardless of treatment with maraviroc. Maraviroc was well tolerated and improved patient quality of life.

Anonymous Patient Answer

Is maraviroc safe for people?

Most people do not need to be treated for 3 weeks prior to starting maraviroc and one week during treatment. Those taking zidovudine for HIV treatment or receiving zidovudine or zalcitabine for other diagnoses do not require any drug interaction warnings.

Anonymous Patient Answer

How serious can hiv infections be?

The presence of HAARTs does not seem to have a substantial impact on the patient's immune status and the likelihood of developing opportunistic infections. To confirm these data, the sample size of this study was too small to be considered reliable.

Anonymous Patient Answer

What does maraviroc usually treat?

Maraviroc can be effective and well tolerated in patients with all known manifestations of infection with HCV, including those in the presence of resistance-associated mutations in the viral HCV polymerase. It is effective and well tolerated in a small number of patients with genotype-1 and genotype-4 infection.

Anonymous Patient Answer
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