Study investigating a new medicine - MK-1439 in patients diagnosed with HIV-1 without previous treatment for this disease. The study has 2 parts and neither the doctor or patient will know the treatment group. All the patients will be treated with Truvada, some of the patients will be treated in addition with MK-1439, while the others will be treated in addition with Efavirenz.
- Conditions
- Human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral naïve HIV-infected patients.MedDRA version: 17.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-001573-93-BE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 320
1. Patient is a male or female of at least 18 years of age on the day of signing the informed consent. Patient provides written informed consent for the trial. The patient will also provide consent for Future Biomedical Research; however, the patient may participate in the main trial without participating in Future Biomedical Research.
2. Patient is HIV-1 positive as determined by a positive ELISA and has screening plasma HIV RNA (completed by the central laboratory) = 1,000 copies/mL within 45 days prior to the treatment phase of this study.
3. Patient has a screening CD4 cell count =100 cells/mm3(completed by the central laboratory) within 45 days prior to the treatment phase of this study.
4. Patient is naïve to antiretroviral therapy (ART). 5. Patient has had the following laboratory values within 45 days prior to the treatment phase of this study:
a) Serum creatinine within normal limits.
b) INR =1.2
c) Urinalysis within normal limits.
Note: Clinically insignificant abnormalities on urinalysis may be permitted after retest, provided these are documented as clinically insignificant per investigator.
d) Hemoglobin =9.0 g/dL (if female) or =10.0 g/dL (if male).
e) Absolute neutrophil count =1000/mm3.
f) Platelet count =100,000/ mm3.
g) Total serum bilirubin less than or equal to the upper limit of normal.
h) Alkaline phosphatase <1.5 x upper limit of normal.
i) AST (SGOT) and ALT (SGPT) <1.5 x upper limit of normal.
6. In the opinion of the investigator, the patient should be considered clinically stable with no signs or symptoms of acute 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.
7. Patient who is of reproductive potential agrees to:
• True abstinence: Abstinence is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., abstinence only on certain calendar days, abstinence only during ovulation period, use (or have their of symptothermal method, use of post-ovulation method) and withdrawal are not acceptable methods of contraception].
• Personal use (or partner use) of 2 acceptable methods of birth control throughout the study and for 12 weeks post study. Acceptable methods of birth control are: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, implantable contraceptives and vasectomy.
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 315
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1. Male patient is planning to impregnate or provide sperm donation for the duration of the study plus an additional 12 weeks. Female patient is pregnant or breast-feeding, or expecting to conceive or donate eggs for the duration of the study plus an additional 12 weeks.
2. Patient has received any approved or experimental antiretroviral agents or is anticipated to receive such medications (beyond those outlined as study medication in this protocol) during the course of the study.
3. Patient has used any immunomodulators or immunosuppressive therapy within one month prior to treatment in this study. Short courses of corticosteroids (e.g., as for asthma exacerbation) are allowed.
4. Patient requires or is anticipated to require any of the prohibited medications noted in Section 3.2.1.
5. Patient has been treated for a viral infection other than HIV, such as hepatitis B, with an agent that is active against HIV including but not limited to adefovir, tenofovir disoproxil fumarate, lamivudine, emtricitabine, or entecavir. Note: Patients may be enrolled if treatment occurred prior to the diagnosis of HIV.
6. Patient has significant hypersensitivity or other contraindication to any of the components of the study drugs (emtricitabine, tenofovir disoproxil fumarate, and/or efavirenz).
7. Patient has documented or known HIV resistance to emtricitabine, tenofovir disoproxil fumarate, and/or efavirenz, based on genotypic resistance analysis.
8. Patient has a history of renal or urinary obstructive disease, requires dialysis (hemodialysis, continuous ambulatory peritoneal dialysis [CAPD], or other forms of dialysis), or has a calculated creatinine clearance at time of screening of =80 mL/min, based on the Cockcroft-Gault equation which is as follows (and 0.85 times this value for females): Clcr (mL/min) = (140–age) x weight (in kg)____ 72 x serum creatinine (mg/dL)
9. Patient with active Hepatitis C virus (HCV) co-infection (defined as detectable HCV RNA) or Hepatitis B virus (HBV) co-infection (defined as HBsAg positive). Patients with prior/inactive HCV infection (defined as undetectable HCV RNA) or past HBV infection (defined as HBsAg negative and HBsAb positive) may be enrolled. 10. Patient has a history of alcohol or other substance abuse which in the opinion of the investigator would interfere with patient compliance or safety.
11. Patient has any condition or prestudy laboratory abnormality, or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the patient.
12. Patient has participated in a study with an investigational compound/device within one month of signing informed consent or is anticipating to participate in such a study involving an investigational compound/device during the course of this study.
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