A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naive women

Study ID
STU 072013-052

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Minerva Santos
214-590-2794
minerva.santos@utsouthwestern.edu

Principal Investigator
Mamta Jain

Summary

This study is a 48 week Phase iiib randomized, open-label, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in approximately 474 HiV-1 infected aRT-naive women.

Participants will be randomized into one of 2 groups:

Group a: 48 weeks of treatment with DTG/aBC/3TC (50mg/600mg/300mg). after 48 weeks, participants may choose to stay on this drug and come in to the clinic for visits every 12 weeks until this drug becomes available from the pharmacist or the drug no longer works.

Group B: 48 weeks of treatment with aTV (300mg) +RTV (100mg) + TDF/FTC FDC (300mg/200mg). after 48 weeks, participants will have completed the study and no longer receive any HiV drugs as a part of the study.

Primary endpoint
The primary endpoint for this study will be the proportion of subjects with plasma HiV-1 Rna [Less Than]50 copies/mL at Week 48 using the Snapshot algorithm (Missing, Switch or Discontinuation [?] Failure) for the iTT-e population.


Secondary endpoints

- Proportion of subjects with plasma HiV-1 Rna [Less Than]50 and [Less Than]400 c/mL over time;
- absolute values and change from Baseline in plasma HiV-1 Rna over time;
- absolute values and changes from Baseline in CD4+ cell counts over time;
- incidence of disease progression (HiV-associated conditions, aiDS and death).

Participant Eligibility

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[Single Quote]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-naive (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[Single Quote]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.