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Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

EVG

RTV

ARV regimen

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Phase 2, Open-label, Rollover, Integrase Inhibitor, Antiretroviral Agents, Highly Active Antiretroviral Activity, HAART, HIV, HIV-1, AIDS virus, Human Immunodeficiency Virus, Acquired Immune Deficiency Syndrome Virus, treatment experienced

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Completion of a prior EVG+RTV treatment study without treatment-limiting toxicity.
Males and females of childbearing potential must agree to utilize effective contraception methods.
Ability to understand and sign a written informed consent form.

Exclusion Criteria:

Females who are pregnant or breastfeeding.
Participation in any other clinical trial without prior approval from the Sponsor.
Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study.
Subjects receiving ongoing therapy with contraindicated drugs.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EVG+RTV

Arm Description

EVG 85 mg or 150 mg + RTV + ARV regimen Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen will receive EVG 85 mg and all other participants will receive EVG 150 mg. Some participants may receive EVG 300 mg during the course of protocol amendment 2.

Outcomes

Primary Outcome Measures

Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event

Secondary Outcome Measures

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.

Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.

Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality

A 'marked abnormality' was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline.

Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

Incidence of Mortality

The percentage of participants who died was summarized.

Full Information

NCT ID

NCT00445146

First Posted

February 28, 2007

Last Updated

March 23, 2016

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00445146

Brief Title

Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Phase 2, Open-label, Rollover, Integrase Inhibitor, Antiretroviral Agents, Highly Active Antiretroviral Activity, HAART, HIV, HIV-1, AIDS virus, Human Immunodeficiency Virus, Acquired Immune Deficiency Syndrome Virus, treatment experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

192 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EVG+RTV

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

EVG

Other Intervention Name(s)

Vitekta®, GS-9137

Intervention Description

Elvitegravir (EVG) tablet administered orally once daily with food

Intervention Type

Drug

Intervention Name(s)

RTV

Other Intervention Name(s)

Norvir®

Intervention Description

Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food

Intervention Type

Drug

Intervention Name(s)

ARV regimen

Intervention Description

The components of the 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).

Primary Outcome Measure Information:

Title

Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event

Time Frame

Up to Week 408 plus 30 days

Secondary Outcome Measure Information:

Title

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

Description

Time Frame

Up to Week 408 plus 30 days

Title

Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality

Description

Time Frame

Up to Week 408 plus 30 days

Title

Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality

Description

A 'marked abnormality' was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline.

Time Frame

Up to Week 408 plus 30 days

Title

Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

Time Frame