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HIV InfectionsPhase 2NCT00445146

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

A Phase 2 study testing EVG, RTV and ARV regimen in people with HIV Infections, run by Gilead Sciences at 48 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
HIV Infections
What is being tested?
EVG, RTV and ARV regimen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
48 sitesin 2 countries
Study dates
Feb 2007to Mar 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

48 sites in 2 countries.

48 sites in 2 countries

United States47 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Annandale, Virginia, 22003

  • Study site

    Atlantis, Florida, 33462

  • Study site

    Baltimore, Maryland, 21205

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Chicago, Illinois, 60657

  • Study site

    Costa Mesa, California, 92626

  • Study site

    Dallas, Texas, 75204

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Durham, North Carolina, 27110

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Henderson, Nevada, 89074

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Hillsborough, New Jersey, 08844

  • Study site

    Houston, Texas, 77030

  • Study site

    Huntersville, North Carolina, 28078

  • Study site

    Little Rock, Arkansas, 72207

  • Study site

    Long Beach, California, 90813

  • Study site

    Los Angeles, California, 90033

  • Study site

    Macon, Georgia, 31201

  • Study site

    Manhasset, New York, 11030

  • Study site

    Manors, Florida, 33305

  • Study site

    Memphis, Tennessee, 38105

  • Study site

    Miami, Florida, 33136

  • Study site

    New York, New York, 10016

  • Study site

    Newport Beach, California, 92663

  • Study site

    North Miami Beach, Florida, 33169

  • Study site

    North Palm Beach, Florida, 33408

  • Study site

    Norwalk, Connecticut, 06851

  • Study site

    Orlando, Florida, 32803

  • Study site

    Palo Alto, California, 94305

  • Study site

    Pheonix, Arizona, 85006

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Saint Louis, Michigan, 63108

  • Study site

    San Diego, California, 92103

  • Study site

    San Francisco, California, 94110

  • Study site

    Santa Fe, New Mexico, 87505

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Seattle, Washington, 98101

  • Study site

    Stony Brook, New York, 11794

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tampa, Florida, 33602

  • Study site

    The Bronx, New York, 11030

  • Study site

    Washington D.C., District of Columbia, 20037

  • Study site

    West Springfield, Massachusetts, 01107

Other trials in United States

Puerto Rico1 site

  • Study site

    Santurce, 00921

Other trials in Puerto Rico

About this study

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

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
Being tested
EVG, RTV, ARV regimen
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
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EVGDrug

    Also called Vitekta®, GS-9137

    Elvitegravir (EVG) tablet administered orally once daily with food

  • RTVDrug

    Also called Norvir®

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

  • ARV regimenDrug

    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).

Study groups in NCT00445146
Study groupRoleWhat they receive
EVG+RTVExperimentalEVG 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.
Receives: Drug: EVG; Drug: RTV; Drug: ARV regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to Week 408 plus 30 days

Secondary outcomes (15)

  1. 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.

    Measured: Up to Week 408 plus 30 days

  2. 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.

    Measured: Up to Week 408 plus 30 days

  3. 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.

    Measured: Up to Week 408 plus 30 days

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  12. 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

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

  13. 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

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

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

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

  15. Incidence of Mortality

    The percentage of participants who died was summarized.

    Measured: Up to Week 408 plus 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00445146
Sponsor's protocol ID
GS-US-183-0130
Status last verified
Mar 2016
First submitted
28 Feb 2007
Last updated
25 Apr 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EVG, RTV and ARV regimen in people with HIV Infections, run by Gilead Sciences at 48 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event (time frame: Up to Week 408 plus 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00445146.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2016.

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