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

NCT00445146 | Completed Phase 2 Results

• 1 other identifier: GS-US-183-0130
• Study Type: interventional
• Target: 192
• Locations: 2 countries
• Sites: 48

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  Up to Week 408 plus 30 days

Secondary Outcomes (15)

• Percentage of Participants Experiencing Treatment-Emergent Adverse Events

  Up to Week 408 plus 30 days

• Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality

  Up to Week 408 plus 30 days

• Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality

  Up to Week 408 plus 30 days

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

  Baseline; 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

  Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

Study Arms (1)

EVG+RTV

EXPERIMENTAL

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.

Drug: EVG; Drug: RTV; Drug: ARV regimen

Interventions

EVG DRUG

Elvitegravir (EVG) tablet administered orally once daily with food

Also known as: Vitekta®, GS-9137

EVG+RTV

RTV DRUG

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

Also known as: Norvir®

EVG+RTV

ARV regimen DRUG

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).

EVG+RTV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (48)

Unknown Facility

Pheonix, Arizona, 85006, United States

Location

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Little Rock, Arkansas, 72207, United States

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Beverly Hills, California, 90211, United States

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Costa Mesa, California, 92626, United States

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Fountain Valley, California, 92708, United States

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Long Beach, California, 90813, United States

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Los Angeles, California, 90033, United States

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Newport Beach, California, 92663, United States

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Palo Alto, California, 94305, United States

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San Diego, California, 92103, United States

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San Francisco, California, 94110, United States

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Norwalk, Connecticut, 06851, United States

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Washington D.C., District of Columbia, 20037, United States

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Atlantis, Florida, 33462, United States

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Fort Lauderdale, Florida, 33308, United States

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Manors, Florida, 33305, United States

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Miami, Florida, 33136, United States

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North Miami Beach, Florida, 33169, United States

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North Palm Beach, Florida, 33408, United States

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Orlando, Florida, 32803, United States

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Sarasota, Florida, 34239, United States

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Tampa, Florida, 33602, United States

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Decatur, Georgia, 30033, United States

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Macon, Georgia, 31201, United States

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Chicago, Illinois, 60657, United States

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Baltimore, Maryland, 21205, United States

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Boston, Massachusetts, 02215, United States

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West Springfield, Massachusetts, 01107, United States

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Saint Louis, Michigan, 63108, United States

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Henderson, Nevada, 89074, United States

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Hillsborough, New Jersey, 08844, United States

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Santa Fe, New Mexico, 87505, United States

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Albany, New York, 12208, United States

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Manhasset, New York, 11030, United States

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New York, New York, 10016, United States

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Stony Brook, New York, 11794, United States

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The Bronx, New York, 11030, United States

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Durham, North Carolina, 27110, United States

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Huntersville, North Carolina, 28078, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19107, United States

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Memphis, Tennessee, 38105, United States

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Dallas, Texas, 75204, United States

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Houston, Texas, 77030, United States

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Annandale, Virginia, 22003, United States

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Seattle, Washington, 98101, United States

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Tacoma, Washington, 98405, United States

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Santurce, 00921, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

elvitegravir; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@Gilead.com

Study Officials

• Martin Rhee, MD

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 8, 2007
• Study Start: February 1, 2007
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 25, 2016
• Results First Posted: April 25, 2016

Record last verified: 2016-03

Locations

PR (1); US (47)