Study investigating a new medicine - Doravirine in patients diagnosed with HIV-1 without previous treatment for this disease. Neither the doctor or patient will know the treatment group. All the patients will be treated with Truvada or Epzicom/Kivexa, some of the patients will be treated in addition with Doravirine, while the others will be treated in addition with Darunavir plus Ritonavir.
- Conditions
- Human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral naïve HIV-infected patients.MedDRA version: 17.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-001127-69-PT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 680
1. be at least 18 years of age on the day of signing the informed consent.
2. understand the study procedures and voluntarily agree to participate
by giving written informed consent (or have a legal representative
provide written informed consent) for the trial. The subject or their legal representative may also provide consent for Future Biomedical research. However, the subject may participate in the main trial without participating in Future Biomedical research.
3. be HIV-1 positive as determined by a positive result on an enzyme-immuno assay, have screening plasma HIV-1 RNA (determined by the central laboratory) =1000 copies/mL within 45 days prior to the treatment phase of this study, and have HIV treatment indicated based on physician assessment. Local treatment guidelines should be considered in the decision to initiate therapy.
4. be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
Note: Naïve is defined as having received no (0 days of) ART therapy for the treatment of HIV infection.
5. have the following laboratory values at screening within 45 days prior to the treatment phase of this study:
- Alkaline phosphatase =3.0 x upper limit of normal
- AST (SGOT) and ALT (SGPT) =5.0 x upper limit of normal
Note: A single repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results.
6. have a calculated creatinine clearance at time of screening =50 mL/min, based on the Cockcroft-Gault equation which is as follows :
Clcr (mL/min) = (140-age) x weight (in kg)/72 x serum creatinine (mg/dL) for males and
Clcr (mL/min) = [(140-age) x weight (in kg)/72 x serum creatinine (mg/dL)] x 0.85 for females
7. in the opinion of the investigator, be considered clinically stable with no signs or symptoms of active infection, at the time of entry into the study (i.e., clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study).
8. be highly unlikely to become pregnant or to impregnate a partner since the subject meets at least one of the following categories:
a) The subject is a male who is not of reproductive potential, defined as a male who has azoospermia (whether due to having had a vasectomy or due to an underlying medical condition).
b) The subject is a female who is not of reproductive potential, defined as a female who either: (1) is postmenopausal (defined as at least 12 months with no menses in women =45 years of age); (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR (3) has a congenital or acquired condition that prevents childbearing.
c) The subject is a female or a male who is of reproductive potential and
agrees to avoid becoming pregnant or impregnating a partner while
receiving study drug and for 14 days after the last dose of study drug by
complying with one of the following: (1) practice abstinence† from
heterosexual activity OR (2) use (or have their partner use) acceptable
contraception during heterosexual activity.
Contraceptives containing ethinyl estradiol cannot be used as a method
of birth control in this study due to an interaction with ritonavir which
may reduce their effectiveness. Therefore, it is recommended that a
condom or other non-hormonal method of contraception should be used instead. Acceptable
The subject must be excluded from participating in the trial if the subject:
1. has a history or current evidence of any condition, therapy, laboratory abnormali ty or other circumstance that might confound the results of the study or interfere with the subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
2. is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence. The nature and potential clinical context of the subject's illicit drug use, in relation to their exclusion from this trial, will be at the discretion of the Investigator.
3. has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1, including but not limited to adefovir, tenofovir, entecavir, emtricitabine, or lamivudine.
Note: Subjects may be enrolled if treatment occurred prior to the diagnosis of HIV.
4. has documented or known resistance to study drugs including MK-1439, darunavir, ritonavir, emtricitabine, tenofovir, abacavir and/or lamivudine, as defined below:
a. Resistance to MK-1439, for the purpose of this study, includes mutants containing the following mutations: L100I, K101E, K101P, K103N, K103S, V106A, V106I, V106M, V108I, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, Y188C, Y188H, Y188L, G190A, G190S, H221Y, L234I, P225H, F227C, F227L, F227V, M230L, M230I.
b. Resistance to darunavir/ritonavir includes any of the following PI mutations: V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, or L89V.
c. Resistance to emtricitabine, tenofovir, abacavir and lamivudine includes the following mutations: M184V/I, K65R, M41L, D67N, K70R/E, T69S, L210W,
T215Y/F, K219Q/E, L74V, and Y115F.
5. has participated in a study with an investigational compound/device within 30 days prior to signing informed consent or anticipates participating in such a study involving an investigational compound/device during the course of this study.
6. has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study.
Note: Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed.
7. requires or is anticipated to require any of the prohibited medications noted in the protocol (Refer to Section 5.5).
8. has significant hypersensitivity or other contraindication to any of the components of the study drugs.
9. has a current (active) diagnosis of acute hepatitis due to any cause.
Note: Subjects with chronic hepatitis B and C may enter the study as long as they fulfill all entry criteria, have stable liver function tests, and have no significant impairment of hepatic synthetic function (significant impairment of hepatic synthetic function is defined as a serum albumin <2.8 mg/dL or an INR >1.7 in the absence of another explanation for the abnormal laboratory value).
10. is pregnant, breastfeeding, or expecting to conceive at any time during the study.
11. is female and is expecting to donate eggs at any time during the study or is male and is expecting to donate sperm at any time during the study.
12 is or has an immediate family member (spouse or children) who is investigational site or sponsor staff directly involved with this trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method