PH3b, DTG Study in HIV-1 Subjects Completing IMPAACT Study P1093
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| ClinicalTrials.gov Identifier: NCT03016533 |
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Recruitment Status :
Recruiting
First Posted : January 10, 2017
Last Update Posted : July 26, 2019
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Sponsor:
ViiV Healthcare
Information provided by (Responsible Party):
ViiV Healthcare
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Brief Summary:
Dolutegravir (DTG) is a potent inhibitor of the human immunodeficiency virus type 1 (HIV-1) integrase that has been developed for the treatment of HIV. This is a phase 3b (PH3b), non-randomized, open-label, multi-center, treatment rollover study. The primary objective of this pediatric interventional study is to provide continued access to DTG for eligible subjects who successfully completed participation in the international maternal pediatric adolescent acquired immunodeficiency syndrome [AIDS] clinical trials (IMPAACT) P1093 study (parent study) and who cannot locally access DTG in the public sector. The P1093 study was designed to evaluate the pharmacokinetics (PK), safety, tolerability and antiviral activity of DTG in HIV-1 experienced adolescents and children as well as treatment-naive infants and toddlers. Subjects who have tolerated DTG in the parent study without any significant toxicity leading to the permanent discontinuation of this drug and withdrawal from the parent study will be considered for this open-label continued access study. Subjects will be receiving their age/weight appropriate dose of DTG as defined in the parent study. The objective of this study will be supported through evaluation of serious adverse events. The duration of subject accrual into the study will extend until DTG receives local (by country) regulatory approval . Therefore, subjects enrolled into this study will be those who will benefit from treatment and will continue to receive DTG until local (by country) regulatory approval and commercial or other availability occurs from another source (e.g. government programs, aid programs, assistance programs, etc.). Subjects will be enrolled after all screening procedures have been completed. In most cases, the Screening visit will overlap with the subject's penultimate visit on the parent study (at Week 180 of P1093). Subjects who meet all entry criteria may enroll and will be seen in the clinic every 12 weeks for a safety evaluation and to receive DTG. It is estimated that no more than 300 subjects will be enrolled in this study.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Dolutegravir film-coated tablets Drug: Dolutegravir film-coated dispersible tablets | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Open-label Access to Dolutegravir for HIV-1 Infected Children and Adolescents Completing IMPAACT Study P1093 |
| Actual Study Start Date : | June 7, 2017 |
| Estimated Primary Completion Date : | December 29, 2023 |
| Estimated Study Completion Date : | December 29, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dolutegravir Continued Access
All subjects will receive dolutegravir film-coated tablets or film-coated dispersible tablets at appropriate doses selected as per their age and weight bands. For those subjects who were previously receiving dolutegravir in study P1093 (parent study), dolutegravir will be supplied as film-coated tablets containing 10 mg, 25 mg and 50 mg of dolutegravir and 5 mg film-coated dispersible tablets of dolutegravir. Subjects will receive dolutegravir until age-appropriate formulations are available to them from some other source, or until subject is no longer deriving benefit from treatment, or subject are discontinued, or until development of dolutegravir is terminated. The dose adjustment will be made if a subject's weight change requires a dose adjustment. Aging subjects (those who crosses age-boundaries) who are taking the dispersible tablet formulation will be allowed to switch to the tablet formulation once daily if they are able to swallow the tablet.
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Drug: Dolutegravir film-coated tablets
Dolutegravir film-coated tablets will be provided as 10 mg, 25 mg and 50 mg tablets. It will be administered at the dose of approximately 1 mg/kilogram (kg) with maximum dose of 50 mg to subjects as per their age and weight band. Drug: Dolutegravir film-coated dispersible tablets Dolutegravir film-coated dispersible tablets will be provided as 5 mg dispersible tablets. It will be administered at the appropriate dose as determined by results of the parent protocol to subjects as per their age and weight band. |
Primary Outcome Measures :
- Continued access to dolutegravir [ Time Frame: Up to 2 years ]To provide access to dolutegravir in an open-label protocol to eligible subjects who have completed the P1093 study.
Secondary Outcome Measures :
- Incidence and severity of serious adverse events (SAEs) as a measure of safety [ Time Frame: Up to 2 years ]An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function.
- Number of subjects with any clinical or laboratory adverse events leading to discontinuation of dolutegravir [ Time Frame: Up to 2 years ]An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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| Ages Eligible for Study: | up to 25 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Between >=4 weeks and <18 years of age inclusive, at the Day 1 visit for the P1093 study.
- Subjects must have successfully completed participation in the P1093 study (parent study) through at least Week 180. Subjects with evidence of virologic failure (VF) in the parent study must have eligibility for this study discussed and agreed with the ViiV Healthcare Medical Monitor.
- Subjects must have virological control defined as HIV-1 ribonucleic acid (RNA) <400 copies per milliliter (c/mL) during the parent study at their penultimate P1093 visit (on or after the Week 180 visit). If the penultimate P1093 visit on or after the Week 180 visit indicates the possibility of VF, a retest can be used to confirm eligibility. Adherence issues should be addressed and viral suppression must be confirmed prior to Day 1.
- Demonstrated ability or willingness to swallow assigned dolutegravir (DTG) tablets (for subjects requiring tablets).
- All subjects who are engaging in sexual activity should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g. male condom) and on the risk of HIV transmission to an uninfected partner. Female subjects who are of child bearing potential and who are engaging in sexual activity that could lead to pregnancy, must use 2 adequate birth control methods while on study and for 2 weeks after stopping study drug. Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.
- Parent, legal guardian or subject >=18 years of age is able and willing to provide signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Exclusion Criteria:
- Presence of any active AIDS defining opportunistic infection.
- Known >=grade 3 laboratory toxicities prior to study entry (e.g. neutrophil count, hemoglobin, platelets, aspartate aminotransferase [AST], aspartate aminotransferase [ALT], lipase, serum creatinine and total bilirubin). Repeat testing will be allowed for eligibility determination. >=grade 3 total bilirubin is allowable, if the subject is on atazanavir (ATV). Subjects with laboratory abnormalities considered unrelated to DTG may be allowed to enter the study. Thus, if the laboratory abnormality persists upon repeat testing, the subject may be considered for study entry after consultation and approval of the study team.
- Subjects who were permanently discontinued from DTG in the parent study due to intolerance or pregnancy must not be included in this current program.
- The following liver toxicities within 30 days prior to study entry: ALT >3 times upper limit of normal (ULN) and direct bilirubin is >2 times ULN.
- Women who are pregnant or plan to become pregnant or breastfeed during the study.
- Subject is currently participating in or has participated in a study with a compound or device that is not commercially available within 30 days of signing informed consent, unless permission from the sponsor's medical monitor is granted.
- Presence of any history of allergy/sensitivity to any of the study drugs.
- Use of any disallowed medications at time of screening.
- Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
- Clinical or symptomatic evidence of pancreatitis, as determined by the clinician.
- Any condition (including but not limited to alcohol and drug use) that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016533
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
Locations
| United States, California | |
| GSK Investigational Site | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Jaime G DeVille | |
| Brazil | |
| GSK Investigational Site | Recruiting |
| Belo Horizonte, Minas Gerais, Brazil, 30130-100 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Jorge Pinto | |
| GSK Investigational Site | Recruiting |
| Nova Iguacu, Rio De Janeiro, Brazil, 26030-380 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Ivete Gomes | |
| GSK Investigational Site | Recruiting |
| Rio de Janeiro, Brazil, 21941-612 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Ricardo Hugo Oliveira | |
| South Africa | |
| GSK Investigational Site | Recruiting |
| Hillbrow, Gauteng, South Africa, 2001 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Lee Fairlie | |
| Thailand | |
| GSK Investigational Site | Recruiting |
| Bangkok, Thailand, 10700 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Kulkanya Chokephaibulkit | |
| GSK Investigational Site | Recruiting |
| Changklan, Muang, Thailand, 50100 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Gonzague Jourdain | |
| GSK Investigational Site | Recruiting |
| Chiang Mai, Thailand, 50200 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Virat Sirisanthana | |
Sponsors and Collaborators
ViiV Healthcare
Investigators
| Study Director: | GSK Clinical Trials | ViiV Healthcare |
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT03016533 |
| Other Study ID Numbers: |
205858 |
| First Posted: | January 10, 2017 Key Record Dates |
| Last Update Posted: | July 26, 2019 |
| Last Verified: | July 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by ViiV Healthcare:
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Dolutegravir Continued access study HIV-1 GSK1349572 Pediatric |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Dolutegravir HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |