Study to compare a standard HIV regimen with dolutegravir/abacavir/lamivudine in wome

Phase 1

• Conditions: HIV-infection; MedDRA version: 16.0Level: LLTClassification code 10020160Term: HIV diseaseSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-005823-34-IT
• Lead Sponsor: ViiV Healthcare UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-24
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 474

Inclusion Criteria

1. HIV-1 infected females (gender at birth) = 18 years of age;
2. A female, may be eligible to enter and participate in the study if she:
a. is of non-child-bearing potential either defined as post-menopausal (12 months of spontaneous amenorrhea and = 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral
oophorectomy or,
b. is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy:
-Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications;
-Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide);
-Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion, see the SPM for an example listing of approved IUDs);
-Male partner sterilization prior to the female subject’s entry into the study and this male is the sole partner for that subject;
-Any other method with published data showing that the expected failure rate is <1% per year.
- Approved hormonal contraception for subjects randomized to the DTG/ABC/3TC arm (see the SPM for a listing of examples of approved hormonal contraception).
-Approved hormonal contraception and a barrier method for subjects randomized to the ATV+RTV+TDF/FTC arm.
Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of IP.
All subjects participating in the study should be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide).
3. HIV-1 infection as documented by Screening plasma HIV-1 RNA =500 c/mL;
4. Documentation that the subject is negative for the HLA-B*5701 allele;
5. Antiretroviral-naïve (<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection);
6. Signed and dated written informed consent is obtained from the subject or the subject’s legal representative prior to screening;
7. Subjects enrolled in France: a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 464
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in the study:
Exclusionary medical conditions
1. Women who are pregnant or breastfeeding;
2. Women who plan to become pregnant during the first 48 weeks of the study.
3. Any subject who has had a medical intervention for gender reassignment;
4. Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease (Section 11.1). Exceptions include cutaneous Kaposi’s sarcoma not requiring systemic therapy and historic CD4+ cell counts of <200 cells/mm3.
5. Subjects with any degree of hepatic impairment, (Class A or greater) as determined by Child-Pugh classification (Section 11.2). For subjects requiring anticoagulation therapy, discussion with the study medical monitor will be required;
6. Subjects positive for hepatitis B (+HBsAg) at Screening, or anticipated need for HCV therapy during the study;
7. History or presence of allergy to the study drugs or their components or drugs of their class;
8. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator
and the Study medical monitor for inclusion of the subject;
9. Subjects who in the investigator’s judgment, poses a significant suicidality risk.
Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk;
10. History of osteoporosis with fracture or requiring pharmacologic therapy with bisphosphonates (e.g., alendronate, ibandronate, risedronate, zoledronic acid), antiresorptive medications (e.g., denosumab, strontium ranelate, teriparatide), and estrogen receptor modulators (e.g., raloxifene, tamoxifen). Use of calcium and vitamin D is permitted.
Exclusionary Treatments prior to Screening or Day 1
11. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening;
12. Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses (a detailed list is provided in the SPM);
13. Treatment with any agent, except recognized ART as allowed above (Section 4.2), with documented activity against HIV-1 in vitro within 28 days of first dose of IP;
14. Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP;
15. Subjects enrolled in France: the subject has participated in any study using an investigational drug during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer,
prior to screening for the study or the subject will participate simultaneously in another clinical study.
Exclusionary Laboratory Values or Clinical Assessments at Screening
16. Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation [IAS USA, 2012] in the Screening result or, if known, any historical resistance test result. Note: retests of Screening genotypes are not allowed;
17. Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities (total cholesterol, triglycerides, High Density Lipoprotein (HDL)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified