Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients

Sponsor

Agouron Pharmaceuticals (Industry)

Overall Status

Suspended

CT.gov ID

NCT00004999

Collaborator

(none)

350

Enrollment

Locations

6.6

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to look at the effectiveness of giving a new anti-HIV drug (AG1549) plus Viracept (nelfinavir) plus Combivir (a tablet containing zidovudine plus lamivudine) to HIV-infected patients who are not taking anti-HIV drugs.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Lamivudine/Zidovudine Drug: Capravirine Drug: Nelfinavir mesylate	Phase 2

Detailed Description

[Note: As of 2/28/2001, due to toxicity studies and concerns for safety, sites were notified that they need to discontinue patients from the capravirine/placebo arms and continue patients with their background therapies or switch patients to new therapies, as deemed appropriate by the investigators.] Patients are randomized to receive Viracept plus Combivir plus either AG1549 or placebo. Patients remain on their assigned therapy for 48 weeks with one post-therapy follow-up visit. Blood samples are taken regularly to quantify plasma HIV-1 RNA, CD4 and CD8 counts, and peripheral blood mononuclear cells (PBMC). Physical exams, safety assessments, and other tests are also done throughout the study. A blood sample is taken at baseline (pre-dose) for a pharmacokinetics assessment. On Day 8 and at the end of Weeks 4, 8, 16, 24, 36, and 48, pharmacokinetic sampling is done prior to dosing and between 2 to 4 hours post-dose.

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled Study of AG1549 in Combination With Viracept (Nelfinavir Mesylate) and Combivir (Zidovudine + Lamivudine) in Treatment-Naive HIV-Infected Patients

Study Start Date :

Aug 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients may be eligible if they:

Are HIV-positive.
Are at least 18 years old.
Have a CD4 cell count of more than 50 cells/mm3.
Have an HIV level of more than 5000 copies/ml.

Exclusion Criteria

Patients will not be eligible if they:

Have ever taken any of the following anti-HIV drugs: nonnucleoside reverse transcriptase inhibitors (NNRTIs), AG1549, Viracept, zidovudine, lamivudine, or Combivir. Other anti-HIV drugs are allowed only if taken for no more than 30 days with the last dose taken more than 6 months prior to study entry.
Have taken an experimental drug within 28 days of study entry.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Clinical Research Ctr Inc	Tucson	Arizona	United States	85712
2	Univ of Southern California	Los Angeles	California	United States	90033
3	Highland Gen Hosp / San Francisco Gen Hosp	Oakland	California	United States	946021018
4	ViRx Inc	Palm Springs	California	United States	92262
5	Research & Treatment at the California Pacific Med Ctr	San Francisco	California	United States	94114
6	Harbor - UCLA Med Ctr	Torrance	California	United States	90502
7	IDC Research Initiative	Altamonte Springs	Florida	United States	32701
8	Bach and Godofsky	Bradenton	Florida	United States	34205
9	Community Health Care	Fort Lauderdale	Florida	United States	33306
10	Univ of Florida	Jacksonville	Florida	United States	32209
11	Univ of Miami School of Medicine	Miami	Florida	United States	33136
12	South Shore Hosp	Miami	Florida	United States	33139
13	Specialty Med Care Ctrs of South Florida Inc	Miami	Florida	United States	33142
14	Orange County Health Dept	Orlando	Florida	United States	32805
15	Larry Bush	Palm Springs	Florida	United States	33461
16	Infectious Diseases Associates	Sarasota	Florida	United States	34239
17	Infectious Disease Research Institute	Tampa	Florida	United States	33614
18	Treasure Coast Infectious Disease Consultants	Vero Beach	Florida	United States	32960
19	Polk County Health Dept	Winter Haven	Florida	United States	33881
20	Sky Blue	Boise	Idaho	United States	83704
21	Northwestern Univ Med Ctr	Chicago	Illinois	United States	60611
22	The CORE Ctr	Chicago	Illinois	United States	60612
23	Indiana Univ Infectious Disease Research Clinic	Indianapolis	Indiana	United States	46202
24	Univ of Iowa	Iowa City	Iowa	United States	52242
25	Univ of Kansas School of Medicine	Wichita	Kansas	United States	67214
26	University of Louisville / ID Division	Louisville	Kentucky	United States	40202
27	HIV Outpatient Clinics / LA State Univ Med Ctr	New Orleans	Louisiana	United States	70112
28	Fenway Community Health Ctr	Boston	Massachusetts	United States	02115
29	Hawthorne Med Associates / PAACA	New Bedford	Massachusetts	United States	02745
30	Kansas City AIDS Research Consortium	Kansas City	Missouri	United States	64111
31	Univ of Nebraska Medical Ctr	Omaha	Nebraska	United States	681985400
32	Paul Alessi	Cherry Hill	New Jersey	United States	08034
33	VAMC New Jersey Healthcare System	East Orange	New Jersey	United States	07018
34	St Mary's Hosp Family Treatment Ctr	Hoboken	New Jersey	United States	07030
35	Univ of Med & Dentistry of New Jersey	Newark	New Jersey	United States	07103
36	Bentley-Salick Medical Practice PC	New York	New York	United States	10003
37	Univ of Rochester Med Ctr	Rochester	New York	United States	14642
38	Univ of Cincinnati / Holmes Hosp	Cincinnati	Ohio	United States	452670405
39	Med Univ of South Carolina	Charleston	South Carolina	United States	29425
40	Julio Arroyo	West Columbia	South Carolina	United States	29169
41	Southwest Infectious Diseases Associates	Dallas	Texas	United States	75246
42	Univ TX Galveston Med Branch	Galveston	Texas	United States	77555
43	Joseph C Gathe	Houston	Texas	United States	77004
44	Thomas Street Clinic	Houston	Texas	United States	77009
45	Hampton Roads Med Specialists	Hampton	Virginia	United States	23666
46	Wisconsin AIDS Research Consortium	Milwaukee	Wisconsin	United States	53203
47	Canadian HIV Trials Network	Vancouver	British Columbia	Canada
48	QEII Health Science Centre	Halifax	Nova Scotia	Canada
49	Sunnybrook Health Science Centre	Toronto	Ontario	Canada
50	Montreal Chest Institute	Montreal	Quebec	Canada
51	Immunity Care and Research Inc	Santo Domingo		Dominican Republic
52	Univ of Puerto Rico School of Med	Rio Piedras		Puerto Rico	00935
53	Clinical Research Puerto Rico Inc	San Juan		Puerto Rico	009091711