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Dolutegravir for HIV-1 Infection
Study Summary
This trial found that DTG is safe and effective when used with OBT in HIV-1 infected infants, children, and adolescents.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have had cancer before, but it doesn't count if it was just on your skin and was removed.You have signs or symptoms of pancreatitis, as determined by your doctor.The participant or their mother has taken integrase inhibitor medication before giving birth or stopping breastfeeding.You have taken HIV medications in the past, except if it was for preventing transmission to a baby or as a preventive measure.
- Group 1: Cohort III
- Group 2: Cohort I
- Group 3: Cohort IIA
- Group 4: Cohort IIB
- Group 5: Cohort IV
- Group 6: Cohort III-DT
- Group 7: Cohort IV-DT
- Group 8: Cohort V-DT
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still openings to join this research initiative?
"Unfortunately, this trial is no longer open to new enrollees. Initially posted on April 20th 2011 and most recently updated on February 23rd 2022, the study has reached its recruitment goals. However, if you are still looking for similar studies - there are currently 485 trials recruiting participants with HIV infections and 32 involving Dolutegravir (DTG) film-coated tablets that have vacancies."
To what extent has participant enrollment grown in this research initiative?
"At present, this trial is not enrolling patients. First posted on April 20th 2011 and last updated February 23rd 2022, potential participants should instead look to one of the 485 studies recruiting for HIV infections or 32 trials using Dolutegravir (DTG) film-coated tablets."
What aspirations are the researchers hoping to achieve with this investigation?
"This medical trial, which will be scrutinised during a 24-hour period at the 5th day post administration of medication, is primarily examining the Area Under Curve From 0 to 24 Hours (AUC0-24). Furthermore, secondary measures include Maximum Plasma Concentration (Cmax), Percentage of Participants With Grade 3 or Higher Adverse Events Assessed as Related to Study Drug and all AEs or laboratory toxicities classified as Grade 3 or higher. The longterm safety data gathered from this research endeavour shall be available upon completion."
What characteristics make a patient an ideal candidate for this trial?
"According to the criteria set forth for this study, only 181 HIV-positive individuals between 4 weeks and 17 years old may participate."
How many medical centers are facilitating this experiment?
"This clinical trial is enrolling participants at Metropolitan Hosp. NICHD CRS in New york, Massachusetts, Boston Medical Center Ped. HIV Program NICHD CRS in Boston, Illinois and Bronx-Lebanon Hospital Center NICHD CRS in Chicago as well as 17 other locations across the country."
What other experiments have been done to explore the efficacy of DTG film-coated tablets?
"The University of Zurich conducted the initial research on Dolutegravir (DTG) film-coated tablets in 2002. 98 trials have since been completed, with 32 live clinical tests currently being conducted across New york and Massachusetts."
Are elderly individuals allowed to participate in this experiment?
"This medical trial has a minimum age requirement of 4 Weeks and the maximum is 17, as specified in its eligibility criteria."
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