Dolutegravir Expanded Access Study (DEAP)
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| ClinicalTrials.gov Identifier: NCT01536873 |
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Recruitment Status :
Completed
First Posted : February 22, 2012
Last Update Posted : September 30, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infection, Human Immunodeficiency Virus HIV Infections | Drug: Dolutegravir | Not Applicable |
ING114916 is an open-label, multi-center EAP to allow access to patients with HIV-1 infection who have documented raltegravir or elvitegravir resistance, have limited treatment options and require dolutegravir to construct a viable anti-retroviral regimen for therapy. Patients must not be eligible for another ongoing dolutegravir clinical trial in order to participate in this EAP.
The duration of patient accrual into the study will extend until dolutegravir receives local (by country) regulatory approval.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Dolutegravir Open Label Protocol for HIV Infected, Adult and Adolescent Patients With Integrase Resistance |
| Actual Study Start Date : | June 14, 2012 |
| Actual Primary Completion Date : | September 23, 2016 |
| Actual Study Completion Date : | September 23, 2016 |
- Drug: Dolutegravir
Eligible patients will receive DTG 50 mg given orally BID
- Expanded access [ Time Frame: Not applicable for an expanded access study ]To to provide access in an open label protocol program to patients who have documented RAL or ELV resistance, who have limited treatment options and who require DTG to construct a viable ARV regimen for therapy
- Assess adverse events [ Time Frame: Not applicable for an expanded access study ]Assess any serious adverse events (SAEs) and adverse events (AEs) that lead to the discontinuation of DTG 50 mg BID
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years to 99 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Adult subjects greater than 18 years of age 2. Documented HIV-1 RNA >/= 400 c/mL 3. Documented raltegravir or elvitegravir resistance 4. Inability to construct a viable background ART regimen with commercially available medications.
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Exclusion Criteria:
- Creatnine clearance < 30ml/min via Cockcroft-Gault method
- Females who are pregnant and/or breastfeeding
- Patients with known integrase allergic reaction
- ALT > 5 times the ULN within one month of treatment initiation
- ALT > 3 times ULN and total bilirubin >1.5 times ULN
- Evidence of severe hepatic impairment
- Patients eligible for, and have access to, an actively enrolling DTG Phase III clinical study
- Any condition or any active clinically significant disease during screening, anticipated requirement for any prohibited concomitant medications -
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): NCT01536873
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| Study Director: | GSK Clinical Trials | ViiV Healthcare |
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT01536873 |
| Other Study ID Numbers: |
114916 2011-001646-16 ( EudraCT Number ) |
| First Posted: | February 22, 2012 Key Record Dates |
| Last Update Posted: | September 30, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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treatment experienced patients Integrase resistance |
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Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus 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 |