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Integrase Inhibitor

Dolutegravir for HIV-1 Infection

Phase 1 & 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- ARV-treatment experienced (not including receipt of ARVs as prophylaxis or for prevention of perinatal transmission)
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one intensive pk visit between 5 and 10 days of dtg initiation. at intensive pk visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
Awards & highlights

Study Summary

This trial found that DTG is safe and effective when used with OBT in HIV-1 infected infants, children, and adolescents.

Who is the study for?
This trial is for HIV-1 infected infants, children, and adolescents who have a viral load greater than 1,000 copies/mL. Participants can be ARV treatment-experienced or naive but must not have resistance to integrase inhibitors or any history of malignancy. They should be able to swallow medication and commit to the study's procedures.Check my eligibility
What is being tested?
The trial tests Dolutegravir (DTG) in various forms (film-coated tablets, granules for suspension, dispersible tablets) alongside optimized background therapy in young patients with HIV-1. It aims to assess drug safety, tolerability, immune response and how the body processes it.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea or vomiting; allergic reactions; changes in liver function; fatigue; headaches; difficulty sleeping; and possible effects on growth rates or development in children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have taken HIV medications in the past, except if it was for preventing transmission to a baby or as a preventive measure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one intensive pk visit between 5 and 10 days of dtg initiation. at intensive pk visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and one intensive pk visit between 5 and 10 days of dtg initiation. at intensive pk visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK Parameter: Area-under-the-curve From 0 to 24 Hours (AUC0-24)
Secondary outcome measures
Disease Progression as Measured by Change in Centers for Disease Control and Prevention (CDC) Category
Genotypic and Phenotypic Measures of Resistance
Number of Participants Who Died
+16 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Cohort V-DTExperimental Treatment1 Intervention
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets
Group II: Cohort IV-DTExperimental Treatment1 Intervention
Children 6 months to younger than 2 years of age who received DTG dispersible tablets
Group III: Cohort IVExperimental Treatment1 Intervention
Children 6 months to younger than 2 years of age who received DTG granules for suspension
Group IV: Cohort III-DTExperimental Treatment1 Intervention
Children 2 to younger than 6 years of age who received DTG dispersible tablets
Group V: Cohort IIIExperimental Treatment1 Intervention
Children 2 to younger than 6 years of age who received DTG granules for suspension
Group VI: Cohort IIBExperimental Treatment1 Intervention
Children 6 to younger than 12 years of age who received DTG granules for suspension
Group VII: Cohort IIAExperimental Treatment1 Intervention
Children 6 to younger than 12 years of age who received DTG film-coated tablets
Group VIII: Cohort IExperimental Treatment1 Intervention
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,951 Total Patients Enrolled
Andrew Wiznia, M.D.Study ChairJacobi Medical Center
Theodore Ruel, M.D.Study ChairUniversity of California, San Francisco

Media Library

Dolutegravir (DTG) film-coated tablets (Integrase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01302847 — Phase 1 & 2
Human Immunodeficiency Virus Infection Research Study Groups: Cohort III, Cohort I, Cohort IIA, Cohort IIB, Cohort IV, Cohort III-DT, Cohort IV-DT, Cohort V-DT
Human Immunodeficiency Virus Infection Clinical Trial 2023: Dolutegravir (DTG) film-coated tablets Highlights & Side Effects. Trial Name: NCT01302847 — Phase 1 & 2
Dolutegravir (DTG) film-coated tablets (Integrase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01302847 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~13 spots leftby Apr 2025