Safety of Ritonavir-Boosted Elvitegravir Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

HIV Infections Clinical Trial

Official title:

A Phase 2, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9137/r) Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445146
• Other study ID #: GS-US-183-0130
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2007
• Last updated: April 15, 2015
• Start date: February 2007
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being initiated to provide continued access to ritonavir-boosted elvitegravir (EVG/r; GS-9137/r) for those participants currently benefiting from their participation in an ongoing EVG/r study. This study will also provide initial access to EVG/r for those participants who have completed a EVG/r study in which the participant was participating in a treatment arm that did not include EVG/r.

While on study, participants will be monitored for safety using periodic assessments of concomitant medications, adverse events and laboratory tests. Participants will be seen once every 8 weeks for the first 48 weeks of the study. Upon completion of 48 weeks, study visits will occur once every 12 weeks until EVG becomes commercially available, or until Gilead elects to terminate the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Completion of a prior EVG/r treatment study without treatment-limiting toxicity.

• Males and females (of childbearing potential ie, not surgically sterile or at least two years post-menopausal) must agree to utilize effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence, or have a vasectomized partner(confirmed sterile)) 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.

Exclusion Criteria:

• 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 contra indicated drugs.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Elvitegravir
Elvitegravir 150 mg tablet administered orally once daily with food
• Ritonavir
Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food
• ARV regimen
The components of the antiretroviral (ARV) regimen will be selected by the investigator without input from the sponsor. The Antiretroviral Regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine or delavirdine, the protease inhibitors saquinavir, nelfinavir or indinavir, or investigational agents (without sponsor approval).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of study drug-related, treatment-emergent adverse events.	The percentage of participants experiencing study drug-related, treatment-emergent adverse events will be summarized.	Up to 7 years	No
Secondary	Incidence of treatment-emergent adverse events	The percentage of participants experiencing treatment-emergent adverse events will be summarized.	Up to 7 years	No
Secondary	Incidence of treatment-emergent Grade 3 and 4 adverse events	The percentage of participants experiencing treatment-emergent Grade 3 and 4 adverse events will be summarized.	Up to 7 years	No
Secondary	Incidence of study drug-related, treatment-emergent Grade 3 and 4 adverse events	The percentage of participants experiencing study drug-related, treatment-emergent Grade 3 and 4 adverse events will be summarized.	Up to 7 years	No
Secondary	Incidence of treatment-emergent laboratory toxicity	Incidence of treatment-emergent laboratory abnormalities, defined as values that increase at least one toxicity grade from baseline at any time post baseline up to and including the date of last dose of study drug plus 30 days, will be summarized. Graded laboratory abnormalities will be defined using the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.	Up to 7 years	No
Secondary	Incidence of marked treatment-emergent laboratory toxicity	Incidence of marked treatment-emergent laboratory abnormalities, defined as a shift from a baseline Grade 0 to a post-baseline Grade 3 or Grade 4 or from a baseline Grade 1 to a post-baseline Grade 4, will be summarized. Graded laboratory abnormalities will be defined using the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.	Up to 7 years	No
Secondary	Incidence of serious adverse events	The percentage of participants experiencing study serious adverse events will be summarized.	Up to 7 years	No
Secondary	Change from baseline in chemistry and hematology parameters	Chemistry and hematology data (using conventional units) will be summarized by the observed data and by the change from baseline. Graded laboratory abnormalities will be defined using the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.	Up to 7 years	No
Secondary	Change from baseline in log10 HIV-1 RNA		Up to 7 years	No
Secondary	Proportion of participants achieving HIV-1 RNA < 400 copies/mL		Up to 7 years	No
Secondary	Proportion of participants achieving HIV-1 RNA < 50 copies/mL		Up to 7 years	No
Secondary	Change from baseline in CD4 cell count		Up to 7 years	No
Secondary	Incidence of mortality	The incidence of mortality will be summarized.	Up to 7 years	No