Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00002450

Collaborator

(none)

600

Enrollment

Locations

9.8

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Tenofovir disoproxil fumarate	Phase 3

Detailed Description

Patients are randomized 2:1 to add tenofovir DF once daily or placebo to their existing antiretroviral regimen in a blinded manner. Patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs taken prior to study entry. Patients and physicians are strongly discouraged from making changes in their antiviral therapies for at least 24 weeks post-randomization. After Week 24, changes in background antiretroviral therapy are permitted. At 24 weeks post-randomization, patients randomized to receive placebo are crossed over to receive open-label tenofovir DF once daily for the remainder of the 48-week study. While on study drug, patients are monitored for safety using periodic physical examinations and serial laboratory tests. Additionally, changes in plasma HIV RNA levels and CD4 cell counts are monitored to assess antiviral efficacy. At the end of the 48-week study period, patients are rolled over into extended dosing until tenofovir DF is commercially available or Gilead Sciences terminates the study.

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Tenofovir Disoproxil Fumarate in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients

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:

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV-positive.
Have been on stable anti-HIV therapy for at least 8 weeks with no more than 4 anti-HIV drugs at the time of study entry.
Have a viral load (level of HIV in the blood) between 400 and 10,000 copies/ml.
Have good kidney function.
Are 18 to 65 years old.
Agree to use a barrier method of birth control (such as condoms) during the study and for 30 days after.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have a new AIDS-related illness diagnosed within 30 days of study entry.
Have any other serious medical conditions, including kidney or bone disease, an active infection requiring antibiotics, or cancer (other than Kaposi's sarcoma or certain skin cancers).
Have received a vaccine within 30 days of study entry.
Are unable to take medications by mouth.
Have ever taken tenofovir or adefovir dipivoxil.
Have taken certain medications within 30 days of study entry, such as chemotherapy, corticosteroids, medications that affect the kidneys, treatment for Kaposi's sarcoma, or certain experimental drugs.
Abuse alcohol or drugs.
Are pregnant or breast-feeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Phoenix Body Positive	Phoenix	Arizona	United States	85016
3	Ocean View Internal Medicine	Long Beach	California	United States	90803
4	St Mary's Med Ctr	Long Beach	California	United States	90813
5	AIDS Healthcare Foundation-Research Center	Los Angeles	California	United States	90027
6	Kaiser Permanente LAMC	Los Angeles	California	United States	90027
7	LAC / USC Med Ctr / Infectious Diseases	Los Angeles	California	United States	90033
8	Cedars Sinai Med Ctr	Los Angeles	California	United States	90048
9	Tower Infectious Diseases / Med Associates Inc	Los Angeles	California	United States	90048
10	Robert Scott MD	Oakland	California	United States	94609
11	UCSD Med Ctr - Owen Clinic	San Diego	California	United States	921038681
12	Pacific Horizons Med Group	San Francisco	California	United States	94115
13	Kaiser Foundation Hospital	San Francisco	California	United States	94118
14	San Francisco VA Med Ctr	San Francisco	California	United States	94121
15	Harbor UCLA Med Ctr / Research and Educational Institute	Torrance	California	United States	90502
16	Univ of Colorado / Health Science Ctr	Denver	Colorado	United States	80262
17	Yale New Haven Hosp / Nathan Smith Clinic	New Haven	Connecticut	United States	06504
18	Yale-New Haven Hospital	New Haven	Connecticut	United States	06504
19	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
20	Physicans Home Service	Washington	District of Columbia	United States	20037
21	Therafirst Med Ctr	Fort Lauderdale	Florida	United States	33308
22	ARTCTC	Fort Pierce	Florida	United States	34950
23	Steinhart Medical Associates	Miami	Florida	United States	33133
24	Univ of Miami School of Medicine	Miami	Florida	United States	33136
25	Hillsborough County Health Dept	Tampa	Florida	United States	33602
26	Treasure Coast Infectious Disease Consultants	Vero Beach	Florida	United States	32960
27	AIDS Research Consortium of Atlanta Inc	Atlanta	Georgia	United States	30308
28	Ponce de Leon Med Ctr	Atlanta	Georgia	United States	30308
29	Northstar Med Clinic	Chicago	Illinois	United States	60657
30	Bendel Med Research	Lafayette	Louisiana	United States	70503
31	Dr Joel Gallant	Baltimore	Maryland	United States	21205
32	New England Med Ctr	Boston	Massachusetts	United States	02111
33	Massachusetts Gen Hosp	Boston	Massachusetts	United States	02114
34	Harper Hosp	Detroit	Michigan	United States	48201
35	Regions Hosp / HIV/AIDS Program	St. Paul	Minnesota	United States	55101
36	Univ of NM	Albuquerque	New Mexico	United States	87131
37	Albany Med College	Albany	New York	United States	12208
38	Bronx Lebanon Hosp Ctr	Bronx	New York	United States	10457
39	Brookdale Univ Hosp and Med Ctr	Brooklyn	New York	United States	112123198
40	Howard Grossman	New York	New York	United States	10011
41	St Vincent's Hosp	New York	New York	United States	10011
42	Columbia Univ	New York	New York	United States	10032
43	Univ of Rochester Medical Center	Rochester	New York	United States	14642
44	Nalle Clinic / Clinical Research Dept	Charlotte	North Carolina	United States	28207
45	Ian Baird	Columbus	Ohio	United States	43214
46	Remington Davis Inc	Columbus	Ohio	United States	43215
47	Oklahoma Univ Health Science Ctr	Oklahoma City	Oklahoma	United States	73104
48	Pennsylvania State College of Medicine	Hershey	Pennsylvania	United States	17033
49	Miriam Hosp / Brown Univ	Providence	Rhode Island	United States	02906
50	Dallas Veterans Administration Med Ctr	Dallas	Texas	United States	75216
51	Nicholas Bellos	Dallas	Texas	United States	75246
52	Thomas Street Clinic	Houston	Texas	United States	77009
53	Univ of Texas / Thomas Street Clinic	Houston	Texas	United States	77030
54	Univ TX San Antonio Health Science Ctr	San Antonio	Texas	United States	78284
55	Infectious Diseases Physicians Inc	Annandale	Virginia	United States	22003
56	Hampton Roads Med Specialists	Hampton	Virginia	United States	23666
57	Infections Ltd PS	Puyallup	Washington	United States	98371
58	Infections Ltd / Physicians Med Ctr	Tacoma	Washington	United States	98405
59	Ponce Univ Hosp	Ponce		Puerto Rico	00731
60	Clinical Research Puerto Rico Inc	San Juan		Puerto Rico	009091711
61	San Juan AIDS Program	Santurce		Puerto Rico	00908