A study to observe the long-term safety of GS-9137 (which is one of a new class of antiretroviral medications called integrase inhibitors) given with ritonavir, in combination with other antiretroviral agents in subjects who have completed a prior GS-9137/ritonavir (GS-9137/r) study for the treatment of HIV-1 infection.
- Conditions
- Human Immunodeficiency Virus (HIV-1) InfectionMedDRA version: 17.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2007-004736-23-Outside-EU/EEA
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 1000
• Completion of a prior elvitegravir (GS-9137)/r treatment study without treatment-limiting toxicity.
• Males and females (of childbearing potential i.e., not surgically sterile or at least two years post-menopausal) must agree to utilize effective contraception methods while on study treatment and for 30 days following the last dose of study drug.
• The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 379
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 372
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
• Females who are pregnant or breastfeeding.
• Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial.
• Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
• Subjects receiving ongoing therapy with any of the medications listed in the excluded concomitant medication list
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To observe the long-term safety of elvitegravir (GS-9137)/r in combination with other antiretroviral agents in subjects who have completed a prior elvitegravir (GS-9137)/r treatment study.;Secondary Objective: None.;Primary end point(s): The incidence of study drug related, treatment-emergent adverse events.;Timepoint(s) of evaluation of this end point: Until elvitegravir (GS-9137) becomes commercially available, or until Gilead Sciences elects to terminate the study.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Incidence of treatment-emergent adverse events<br>• Incidence of treatment-emergent Grades 3 and 4 adverse events<br>• Incidence of study drug related, treatment-emergent Grade 3 and 4 adverse events<br>• Incidence of treatment-emergent laboratory toxicity<br>• Incidence of marked treatment-emergent laboratory toxicity<br>• Incidence of serious adverse events<br>• Change from baseline in chemistry and hematology over time<br>• Change from baseline in log10 HIV-1 RNA over time<br>• Achievement of HIV-1 RNA < 400 copies/mL over time<br>• Achievement of HVI-1 RNA < 50 copies/mL over time<br>• Change from baseline in CD4 cell count over time<br>• Mortality;Timepoint(s) of evaluation of this end point: Until elvitegravir (GS-9137) becomes commercially available, or until Gilead Sciences elects to terminate the study.