A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy (HAART) in HIV-Positive Patients

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00002426

Collaborator

(none)

390

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Adefovir dipivoxil	N/A

Detailed Description

Patients are randomized to 1 of 2 arms in a 2:1 ratio. Approximately 260 patients receive ADV and approximately 130 patients receive placebo. Patients receive ADV or placebo in addition to L-carnitine and their current stable HAART regimen. Each patient receives blinded study medication for 48 weeks and is evaluated at Weeks 16, 24, and 48. Patients who reach the primary endpoint of virologic failure prior to Week 48 may continue blinded study medication or receive open-label ADV at the investigator's discretion. In both cases, patients continue their study visits as per the original visit schedule. Virologic failure is defined as 2 consecutive HIV-1 RNA measurements, after baseline, above 400 copies/ml (measured by the Roche Amplicor HIV-1 Monitor UltraSensitive assay) drawn at least 14 days apart. All patients who complete study visits without treatment-limiting ADV toxicity may continue open-label ADV in the Maintenance Phase at the discretion of the principal investigator.

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Antiretroviral Therapy (HAART) in HIV Infected Patients With HIV-1 RNA > 50 and <= 400 Copies/Ml

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

You may be eligible for this study if you:

Are HIV-positive.
Have been on a stable HAART regimen consisting of at least 3 antiretroviral drugs for at least 16 weeks prior to study entry.
Have a CD4 count of 50 cells/mm3 or more.
Have a viral load greater than 50 and less than or equal to 400 copies/ml within 14 days prior to study entry.
Have had at least 1 additional viral load in the past that was less than or equal to 400 copies/ml while on your current stable HAART regimen.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pacific Oaks Research	Beverly Hills	California	United States	90211
2	ViRx Inc	Palm Springs	California	United States	92262
3	Ctr for AIDS Research / Education and Service (CARES)	Sacramento	California	United States	95814
4	San Francisco Gen Hosp / UCSF AIDS Program	San Francisco	California	United States	94110
5	Kaiser Foundation Hospital	San Francisco	California	United States	94118
6	San Francisco VA Med Ctr	San Francisco	California	United States	94121
7	Blick Med Associates	Stamford	Connecticut	United States	06901
8	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
9	Dupont Circle Physicians Group	Washington	District of Columbia	United States	200091104
10	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
11	IDC Research Initiative	Altamonte Springs	Florida	United States	32701
12	Community AIDS Resource Inc	Coral Gables	Florida	United States	33146
13	TheraFirst Med Ctrs Inc	Fort Lauderdale	Florida	United States	33308
14	Duval County Health Department	Jacksonville	Florida	United States	32206
15	Health Positive	Safety Harbor	Florida	United States	34695
16	Center for Quality Care	Tampa	Florida	United States	33609
17	Georgia Research Associates	Atlanta	Georgia	United States	30342
18	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
19	Indiana Univ Infectious Disease Research Clinic	Indianapolis	Indiana	United States	46202
20	Johns Hopkins Univ School of Medicine	Baltimore	Maryland	United States	21205
21	Albany Med College	Albany	New York	United States	12208
22	Bentley-Salick Med Practice	New York	New York	United States	10011
23	St Luke Roosevelt Hosp	New York	New York	United States	10011
24	James Jones MD	New York	New York	United States	10019
25	Mount Sinai Med Ctr	New York	New York	United States	10029
26	Wake Forest Univ School of Medicine	Winston Salem	North Carolina	United States	27157
27	Associates of Med and Mental Health	Tulsa	Oklahoma	United States	74114
28	The Research and Education Group	Portland	Oregon	United States	97210
29	Miriam Hosp	Providence	Rhode Island	United States	02906
30	Roger Williams Med Ctr	Providence	Rhode Island	United States	02908
31	Vanderbilt Univ School of Medicine	Nashville	Tennessee	United States	37212
32	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas	United States	75235
33	Univ of Texas Med Branch	Galveston	Texas	United States	77555
34	Thomas Street Clinic	Houston	Texas	United States	77009
35	Univ of Utah Med School / Clinical Trials Ctr	Salt Lake City	Utah	United States	84108
36	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22203
37	N Touch Research Corp	Seattle	Washington	United States	98122
38	St Paul's Hosp	Vancouver	British Columbia	Canada
39	Sunnybrook Health Science Centre	Toronto	Ontario	Canada
40	Centre hospitalier de l'Universite de Montreal (CHUM)	Montreal	Quebec	Canada
41	Hopital Edouard Herriot	Lyon Cedex 03		France
42	Hopital Sainte-Marguerite	Marseille		France
43	Klinikum Der Johann Wolfgang Goethe Universitat	Frankfurt		Germany
44	Universitatskrankenhaus Eppendorf	Hamburg		Germany
45	Klinikum der Ludwig-Maximilians-Universitaet	Muenchen		Germany
46	Chelsea and Westminster Hosp	London		United Kingdom
47	King's College Hospital	London		United Kingdom
48	Royal Free Hosp	London		United Kingdom
49	Senior Lecturer in GU Medicine	London		United Kingdom