HIVPhase 2NCT00298350
Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
A Phase 2 study testing GS-9137 - A Novel HIV-1 Integrase Inhibitor in people with HIV and HIV-1, run by Gilead Sciences at 54 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV, HIV-1, Human Immunodeficiency Virus
- What is being tested?
- GS-9137 - A Novel HIV-1 Integrase Inhibitor
- How many people
- 278 participants
- Where
- 54 sitesin 2 countries
- Study dates
- Feb 2006to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV RNA greater than or equal to 1000 c/mL.
- Failed/Failing protease inhibitor based antiretroviral therapy.
- Stable antiretroviral therapy for greater than or equal to 30 days prior to screening.
- Negative Serum Pregnancy Test.
- GFR by Cockcroft Gault greater than or equal to 80 mL/min.
- AST \& ALT less than or equal to 2.5x ULN.
Show all 12Show fewer
- Total Bilirubin less than or equal to 1.5 mg/dL.
- Albumin greater than 3.5 mg/dL.
- Prothrombin Time INR 1.0-1.4
- Platelets greater than or equal to 50,000.
- Hemoglobin greater than or equal to 8.0 mg/dL.
- Absolute Neutrophil Count greater than or equal to 1000.
Who cannot join
- New AIDS defining condition within 30 days of baseline.
- Prior treatment with HIV-1 integrase inhibitor (except patients from 183-101).
- Ascites or encephalopathy.
- Breast Feeding.
- Cancer Diagnosis (besides Kaposi Sarcoma or Basal Cell Carcinoma).
Trial locations and contacts
54 sites in 2 countries.
54 sites in 2 countries
United States52 sites
Study site
Albany, New York, 12208-3479
Study site
Annandale, Virginia, 22003-7313
Study site
Atlantis, Florida, 33462
Study site
Baltimore, Maryland, 21205
Study site
Beverly Hills, California, 90211
Study site
Boston, Massachusetts, 02215-3318
Study site
Chicago, Illinois, 60657
Study site
Cleveland, Ohio, 44106
Study site
Columbia, South Carolina, 29206
Study site
Dallas, Texas, 75204
Study site
Decatur, Georgia, 30033
Study site
Denver, Colorado, 80220
Study site
Detroit, Michigan, 48202
Study site
Fort Lauderdale, Florida, 33308
Study site
Fountain Valley, California, 92708
Study site
Hampton, Virginia, 23666
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, 60813
Study site
Los Angeles, California, 90033
Study site
Macon, Georgia, 31201
Study site
Manhasset, New York, 11030
Study site
Miami, Florida, 33136
Study site
Milwaukee, Wisconsin, 53226
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
Oakland, California, 94609
Study site
Orlando, Florida, 32803
Study site
Philadelphia, Pennsylvania, 19107
Study site
Phoenix, Arizona, 85006
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
Springfield, Massachusetts, 01107
Study site
St Louis, Missouri, 63108
Study site
Stanford, California, 94305-5107
Study site
Sunnyvale, California, 94086
Study site
Tacoma, Washington, 98405
Study site
Tampa, Florida, 33602
Study site
Torrance, California, 90502
Study site
Vero Beach, Florida, 32960
Study site
Washington D.C., District of Columbia, 20037
Study site
Winston-Salem, North Carolina, 27157-1042
Puerto Rico2 sites
Study site
San Juan, 00921-3201
Study site
Santurce, 00909
About this study
Official title: Phase 2 Study of the Treatment of Antiretroviral Treatment-Experienced Subjects Comparing Ritonavir-Boosted GS-9137 (GS-9137/r) vs. a Comparator Ritonavir-Boosted Protease Inhibitor (CPI/r) in Combination With Background ART.
The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.
- Conditions
- HIV, HIV-1, Human Immunodeficiency Virus
- Being tested
- GS-9137 - A Novel HIV-1 Integrase Inhibitor
- Keywords
- Phase 2, Phase II, Randomized, Controlled, Comparator, Partially Blind, Protease Inhibitors, Integrase Inhibitors, Antiviral Agents, Antiretroviral Agents, ART, ARV, Highly Activity Antiretroviral Therapy, HAART, Treatment Experienced
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-9137 - A Novel HIV-1 Integrase InhibitorDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionJun 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298350
- Sponsor's protocol ID
- GS-US-183-0105
- Status last verified
- Jul 2008
- First submitted
- 28 Feb 2006
- Last updated
- 29 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zolopa AR, Berger DS, Lampiris H, Zhong L, Chuck SL, Enejosa JV, Kearney BP, Cheng AK. Activity of elvitegravir, a once-daily integrase inhibitor, against resistant HIV Type 1: results of a phase 2, randomized, controlled, dose-ranging clinical trial. J Infect Dis. 2010 Mar 15;201(6):814-22. doi: 10.1086/650698.
PubMed 20146631
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the Treatment of Antiretroviral Treatment-Experienced Subjects Comparing Ritonavir-Boosted GS-9137 (GS-9137/r) vs. a Comparator Ritonavir-Boosted Protease Inhibitor (CPI/r) in Combination With Background ART.
- ClinicalTrials.gov ID
- NCT00298350
- Acronym / sponsor ID
- GS-US-183-0105
- Conditions
- HIV, HIV-1, Human Immunodeficiency Virus
- Keywords
- Phase 2, Phase II, Randomized, Controlled, Comparator, Partially Blind, Protease Inhibitors, Integrase Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 2 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- HIV RNA greater than or equal to 1000 c/mL.
- Failed/Failing protease inhibitor based antiretroviral therapy.
- Stable antiretroviral therapy for greater than or equal to 30 days prior to screening.
- Negative Serum Pregnancy Test.
- GFR by Cockcroft Gault greater than or equal to 80 mL/min.
Key exclusion criteria (5 listed)
- New AIDS defining condition within 30 days of baseline.
- Prior treatment with HIV-1 integrase inhibitor (except patients from 183-101).
- Ascites or encephalopathy.
- Breast Feeding.
- Cancer Diagnosis (besides Kaposi Sarcoma or Basal Cell Carcinoma).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-9137 - A Novel HIV-1 Integrase Inhibitor | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2008.
- Derived from this study: PubMed 20146631Zolopa AR, Berger DS, Lampiris H, Zhong L, Chuck SL, Enejosa JV, Kearney BP, Cheng AK. Activity of elvitegravir, a once-daily integrase inhibitor, against resistant HIV Type 1: results of a phase 2, randomized, controlled, dose-ranging clinical trial. J Infect Dis. 2010 Mar 15;201(6):814-22. doi: 10.1086/650698.
- Gilead WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
54 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GS-9137 - A Novel HIV-1 Integrase Inhibitor in people with HIV and HIV-1, run by Gilead Sciences at 54 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 12 inclusion and 5 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 29 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298350, which also lists 1 linked publication.
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 29 Jul 2008.