HIV-1 infection
Conditions
Interventions
Trade Name: Tivicay
Product Name: DOLUTEGRAVIR
Pharmaceutical Form: Tablet
INN or Proposed INN: dolutegravir
Current Sponsor code: GSK1349572
Other descriptive name: DOLUTEGRAVIR
Concentration unit: m
Sponsors
Unidad de VIH - Servicio de Enfermedades Infecciosas. Hospital de Bellvitge
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1 Male patients 2 Age equal or greater than 18 years old 3 Chronic HIV-1 infection 4 ART-naïve patients 5 Viral load (HIV-1 RNA) > 5000 copies/mL at the baseline visit 6 HLA-B*5701 test negative 7 Signature of the Informed Consent Form previously to the patient inclusion in the study 8. Patients must agree to use an effective method of contraception during heterosexual intercourse throughout the study period and for 30 days after the end of the study. 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 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Chronic Hepatitis B serum markers at the baseline visit (HbsAg+); 2. Chronic Hepatitis C that anticipated need of treatment during the course of the study 3 Severe hepatic inufficiency 4 Renal insufficiency: Estimated glomerular filtrate (MDRD)<60mL/min 5 Active opportunistic infection. 6 Active neoplasm. 7 Documented HIV-1 primary resistance to the study antriretroviral drugs, in basal genotype test. 8 Presence of any Grade IV laboratory abnormality in the laboratory tests performed at the baseline visit. 9 AST or ALT = 3 times the upper normal limit; and/or bilirrubin =1.5 times the upper normal limit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1-. To evaluate the viral load decay (HIV-1 RNA) in semen, in HIV-1 infected patients, naïve, who start ART treatment with ABC/3TC plus DTG and to compare de decay with the viral load decay in plasma and semen, along 24-weeks treatment. 2- To measure the DTG concentrations in plasma in HIV1 infected patients receiving treatment with ABC/3TC plus DTG. 3- To evaluate the penetration of dolutegravir in semen using the [DTGsemen]/ [DTGplasma] ratio;Primary end point(s): - HIV-1 viral load in semen over 24 weeks (basal, day 3, day 7, day 14, day 28, week 12, week 24) - DTG concentrations in semen (week 4 and week 6). ;Timepoint(s) of evaluation of this end point: - HIV-1 viral load in semen over 24 weeks semanas (basal, day 3, day 7, day 14, day 28, week 12, week 24) - DTG concentrations in semen (week 4 and week 6). ;Main Objective: 1- To evaluate the viral load decay (HIV-1 RNA) in semen, in HIV-1 infected patients, naïve, who start ART treatment with ABC/3TC plus DTG, along 24-weeks treatment 2- To evaluate dolutegravir concentrations in semen in HIV-1 infected patients receiving a 24-weeks treatment with ABC/3TC plus DTG | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time (days) to reach undetectable (<40 copies/mL) VL in semen. - HIV-1 viral load in plasma throughout 24 weeks (basal, day 3, day 7, day 14, day 28, week 12, week 24). - Time (days) to obtain an HIV-1(HIV-1) viral load in plasma lower than the lower detectable limit (<40 copies/mL). - DTG concentrations in plasma -[DTGsemen]/ [DTGplasma] ratio ;Timepoint(s) of evaluation of this end point: All study visits. (basal, day 3, day 7, day 14, day 28, week 12, week 24). | — |
Countries
Spain
Contacts
Public ContactArkaitz Imaz
Unidad de VIH - Servicio de Enfermedades Infecciosas. Hospital de Bellvitge
Outcome results
None listed