A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Hum… (NCT01910402) | Clinical Trial Compass
CompletedPhase 3
A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)
United States, Argentina, Canada499 participantsStarted 2013-08-22
Plain-language summary
This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* HIV-1 infected females (gender at birth) \>=18 years of age
* Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)
* HIV-1 infection as documented by Screening plasma HIV-1 RNA \>=500 c/mL.
* Documentation that the subject is negative for the HLA-B\*5701 allele.
* Antiretroviral-naïve (\<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection).
* Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening.
Exclusion Criteria:
* Women who are pregnant or breastfeeding
* Women who plan to become pregnant during the first 48 weeks of the study
* Any subject who has had a medical intervention for gender reassignment
* Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease
* Subjects with any degree of hepatic impairment
* Subjects positive for hepatitis B at Screening, or anticipated need for HCV therapy during the study
* History or presence of allergy to the study drugs or their components or drugs of their class
* Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia
* poses a significant suicidality risk
* History of osteoporosis with fracture or requiring pharmacologic therapy
* Treatment with an HIV-1 immunotherapeutic …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48