CLINICAL TRIAL

Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1)

Newly Diagnosed
Waitlist Available · < 18 · All Sexes · Middelburg, South Africa

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

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About the trial for Human Immunodeficiency Virus Type 1 (HIV-1)

Treatment Groups

This trial involves 2 different treatments. Rilpivirine 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.
Abacavir
DRUG
Emtricitabine
DRUG
Zidovudine
DRUG
Rilpivirine
DRUG
Tenofovir disoproxil fumarate
DRUG
Lamivudine
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
Abacavir
FDA approved
Emtricitabine
FDA approved
Zidovudine
FDA approved
Rilpivirine
FDA approved
Tenofovir disoproxil
FDA approved
Lamivudine
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and younger. You must have received newly diagnosed for Human Immunodeficiency Virus Type 1 (HIV-1). There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Has documented human immuno deficiency virus (HIV-1) infection
Patients who meet the following criteria; a) Cohort 1: Patients Aged greater than or equal to (>=) 12 to less than (<) 18 years, weight is >= 32 kilogram (kg), b) Cohort 2; Aged >= 6 to < 12 years, weight is >= 17 kg
Must have HIV-1 plasma viral load at screening greater than equal to 500 HIV-1 ribonucleic acid (RNA) copies/mL
Have not received treatment with a therapeutic HIV vaccine or an HIV drug with the exception of a single dose of nevirapine (NVP) (Cohort 1 and Cohort 2) or up to 6 weeks of zidovudine (AZT) use (Cohort 2 only) prior to screening to prevent mother-to-child transmission (MTCT)
In the judgment of the investigator, it is appropriate to initiate antiretroviral therapy (ARV) therapy based on a patient's medical condition and taking into account guidelines for the treatment of HIV-1 infection in children of this age group
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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: Week 48 and Week 240 (Cohort 1 only)
Screening: ~3 weeks
Treatment: Varies
Reporting: Week 48 and Week 240 (Cohort 1 only)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 48 and Week 240 (Cohort 1 only).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- 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 Rilpivirine will improve 2 primary outcomes and 6 secondary outcomes in patients with Human Immunodeficiency Virus Type 1 (HIV-1). Measurement will happen over the course of Up to 48 weeks.

Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve (AUC24)
UP TO 48 WEEKS
AUC24 is defined area under the plasma concentration time curve from 0 to 24 hours post dosing of rilpivirine.
UP TO 48 WEEKS
Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Plasma Concentration (Cmax)
UP TO 48 WEEKS
UP TO 48 WEEKS
Number of Patients with Adverse Events
UP TO 244 WEEKS (COHORT 1 ONLY) (INCLUDING 4 WEEK FOLLOW UP VISIT)
Safety measures include adverse events, vital signs, physical examination, hematology, biochemistry and electrocardiogram.
UP TO 244 WEEKS (COHORT 1 ONLY) (INCLUDING 4 WEEK FOLLOW UP VISIT)
Evolution of viral genotype and phenotype
UP TO 48 WEEKS AND 240 WEEKS (COHORT 1 ONLY)
Blood samples will be collected for the determination of HIV-1 genotype and phenotype by the Protocol Virologist based on plasma viral load.
UP TO 48 WEEKS AND 240 WEEKS (COHORT 1 ONLY)
Treatment adherence as measured by the Study Adherence Questionnaire
UP TO 48 WEEKS AND 240 WEEKS (COHORT 1 ONLY)
This endpoint is measured by Study Adherence Questionnaire for children and teenagers. The adherence questionnaire should be completed by by the patient. Ths questionnaire includes questions about the medicine, it's color and dosage.
UP TO 48 WEEKS AND 240 WEEKS (COHORT 1 ONLY)
Percentage of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV-1) Ribonucleic Acid (RNA) level Less Than (<) 50 Copies/mL Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
WEEK 48 AND WEEK 240 (COHORT 1 ONLY)
Time to loss of virologic response algorithm (TLOVR) requires sustained HIV-1 RNA < 50 copies/mL; confirmed HIV-1 RNA more than or equal to (>=) 50 copies/mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation.
WEEK 48 AND WEEK 240 (COHORT 1 ONLY)
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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 human immunodeficiency virus type 1 (hiv-1)?

About 70 percent of all HIV-infected people present with detectable levels of HIV RNA in their blood. Most of those who have detectable levels of HIV RNA in their blood do not have symptoms of HIV infection. The other 30 percent of HIV-infected people are asymptomatic or have few or no symptoms, but those with these symptoms are likely to have a much more rapid rate of progression of disease.

Anonymous Patient Answer

How many people get human immunodeficiency virus type 1 (hiv-1) a year in the United States?

The number of people getting HIV-1 infection in the United States is estimated to reach about 20 million by 2010 and more, and millions will be in the need of long-term treatments or even death. AIDS, the third epidemic of humans, now the pandemic, is a public health disaster. Every year, nearly a million Americans aged 13 through 47 test HIV-positive and every year approximately 250,000 of them die. The main causes of the HIV-1 infection among these 250,000 are unsafe sex and mother-to-child transmission.

Anonymous Patient Answer

Can human immunodeficiency virus type 1 (hiv-1) be cured?

HIV-1 replication persists in CD8 cells, but hTLV-5 integration was not affected by ART. However, hTLV-5 could be blocked by ART, and the integration-free status of the virus in the CD4 population could be maintained.

Anonymous Patient Answer

What are common treatments for human immunodeficiency virus type 1 (hiv-1)?

There are relatively few commonly used treatments for HIV-1. However, there is no consensus on what the most efficacious and least costly combinations of antiretroviral treatments should be. For HIV-1, antiviral treatment is usually started to suppress viral replication, but many infected patients do not require treatment continuously. The advent of highly active antiretroviral therapy (HAART) has dramatically increased lifespan in the HIV-infected population. HAART is the most effective treatment for HIV-infection. There remains a need for effective combinations of antiretroviral therapies, for which the efficacy of most HAART regimens is difficult to estimate because of the high number of treatments available.

Anonymous Patient Answer

What causes human immunodeficiency virus type 1 (hiv-1)?

Results from a recent clinical trial supports the link between homosexual activity and HIV acquisition by demonstrating high prevalence rates of HIV in men in a high incidence MSM population.

Anonymous Patient Answer

What is human immunodeficiency virus type 1 (hiv-1)?

The viral proteins that compose the retrovirus of HIV-1 must enter the host cell in order to infect it. Many viruses have adapted to their host's cellular mechanisms to allow them to enter the cell. This process can be broadly called entry, but it can also be broken down into steps. A schematic model for one specific retrovirus such as HIV-1 is as follows:\n\nEntry and Transcription: HIV-1 enters the cell by recognizing specific cell membranes that possess proteins called receptors on cell membrane of the host. The HIV-1 enters through two known receptors, the primary and secondary receptors, CD4 and CCR5.

Anonymous Patient Answer

Is rilpivirine safe for people?

In the cohort of individuals with HIV-1 infection and with ESRD, rilpivirine has a good safety profile and was not associated with the development of antimyeloperoxidase autoantibodies or an imbalance in the helper T-cell subsets.

Anonymous Patient Answer

What are the common side effects of rilpivirine?

The most common side effects experienced were headache, vomiting, nausea, abdominal pain and diarrhoea. Other side effects (dryness, itch, rash, pruritus and sweating) were reported in less than 2% of the patients receiving rilpivirine.

Anonymous Patient Answer

What is the primary cause of human immunodeficiency virus type 1 (hiv-1)?

HIV-1 is the principal cause of HIV infection and may be responsible for more than 90% of infection among adult men. HIV-1 has a low frequency of mutations compared with HIV-2 and HIV-3. Although it is not yet known how HIV-1 replicates within a host cell, it readily penetrates the host cell and enters into CD4+ T lymphocytes by endocytosis and then fuses with the viral envelope to release the genomic RNA into the cytoplasm. Once in the cytoplasm, the RNA undergoes reverse transcription. The virion is then able to leave and infect other cells.

Anonymous Patient Answer

What does rilpivirine usually treat?

Rilpivirine inhibits HIV in patients with minimal neurological disease. This may be due to its direct effects on HIV. We are currently evaluating the effects of rilpivirine on non-HIV-related neurological diseases.

Anonymous Patient Answer

What is the average age someone gets human immunodeficiency virus type 1 (hiv-1)?

HIV-1 is one of the most prevalent sexually transmitted infections and is spread mostly through oral intercourse. This means oral sex and vaginal intercourse are the main methods of transmission. The average age at sexual debut in both sexes is around 18 years for men and women. The infection rate and the risk of acquiring HIV-1 are different depending on sexual transmission. One of the greatest risks, for either sex, is having multiple sexual activities or having multiple sexual partners at one time. These practices increase the spread of HIV-1. The sex worker population accounts for many cases. In fact, more than half of all cases are transmitted through sex work. Sex with a sex worker increases the risk of one contracting the virus.

Anonymous Patient Answer

What is rilpivirine?

rilpivirine is a potent HIV-1 inhibitor that targets the HIV-1 protease. The unique mechanism of action demonstrated by rilpivirine provides the impetus for rational design of potent and selective HIV-1 protease inhibitors for clinical use.

Anonymous Patient Answer
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