Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.

• Sponsor: Gilead Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00298350
• Collaborator: (none)
• Enrollment: 278
• Locations: 54
• Duration (Months): 16.9
• Patients Per Site: 5.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV; HIV-1; Human Immunodeficiency Virus	Drug: GS-9137 - A Novel HIV-1 Integrase Inhibitor	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 278 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Study Start Date: Feb 1, 2006
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States	85006
2		Little Rock	Arkansas	United States	72207
3		Beverley Hills	California	United States	90211
4		Fountain Valley	California	United States	92708
5		Long Beach	California	United States	60813
6		Los Angeles	California	United States	90033
7		Newport Beach	California	United States	92663
8		Oakland	California	United States	94609
9		San Diego	California	United States	92103
10		San Francisco	California	United States	94110
11		Stanford	California	United States	94305-5107
12		Sunnyvale	California	United States	94086
13		Torrance	California	United States	90502
14		Denver	Colorado	United States	80220
15		Norwalk	Connecticut	United States	06851
16		Washington	District of Columbia	United States	20037
17		Atlantis	Florida	United States	33462
18		Fort Lauderdale	Florida	United States	33308
19		Miami	Florida	United States	33136
20		North Miami Beach	Florida	United States	33169
21		North Palm Beach	Florida	United States	33408
22		Orlando	Florida	United States	32803
23		Sarasota	Florida	United States	34239
24		Tampa	Florida	United States	33602
25		Vero Beach	Florida	United States	32960
26		Decatur	Georgia	United States	30033
27		Macon	Georgia	United States	31201
28		Chicago	Illinois	United States	60657
29		Baltimore	Maryland	United States	21205
30		Boston	Massachusetts	United States	02215-3318
31		Springfield	Massachusetts	United States	01107
32		Detroit	Michigan	United States	48202
33		St. Louis	Missouri	United States	63108
34		Henderson	Nevada	United States	89074
35		Hillsborough	New Jersey	United States	08844
36		Santa Fe	New Mexico	United States	87505
37		Albany	New York	United States	12208-3479
38		Manhasset	New York	United States	11030
39		New York City	New York	United States	10016
40		Huntersville	North Carolina	United States	28078
41		Winston-Salem	North Carolina	United States	27157-1042
42		Cleveland	Ohio	United States	44106
43		Hershey	Pennsylvania	United States	17033
44		Philadelphia	Pennsylvania	United States	19107
45		Columbia	South Carolina	United States	29206
46		Dallas	Texas	United States	75204
47		Houston	Texas	United States	77030
48		Annandale	Virginia	United States	22003-7313
49		Hampton	Virginia	United States	23666
50		Seattle	Washington	United States	98101
51		Tacoma	Washington	United States	98405
52		Milwaukee	Wisconsin	United States	53226
53		San Juan		Puerto Rico	00921-3201
54		Santurce		Puerto Rico	00909

Sponsors and Collaborators

• Gilead Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Gilead Website

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00298350
• Other Study ID Numbers: GS-US-183-0105
• First Posted: Mar 2, 2006
• Last Update Posted: Jul 29, 2008
• Last Verified: Jul 1, 2008

• Keywords provided by , ,: 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
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; HIV Integrase Inhibitors; Integrase Inhibitors

Study Results

No Results Posted as of Jul 29, 2008