Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00051844

Collaborator

(none)

179

Enrollment

Locations

Duration (Months)

3.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus	Drug: Capravirine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

179 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Double Blind- Randomized, Placebo-controlled Study of Two Doses of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Infected Patients Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen

Study Start Date :

Aug 1, 2002

Actual Study Completion Date :

Nov 1, 2004

Outcome Measures

Primary Outcome Measures

The primary objective was to determine whether the addition of capravirine to a regimen of VIRACEPT and 2 new nucleoside reverse transcriptase inhibitors would provide a higher virologic response rate over 48 weeks []
when compared to a 3-drug regimen without capravirine in patients who had experienced virologic failure while on a nonnucleoside reverse transcriptase inhibitor regimen. []

Secondary Outcome Measures

The safety and tolerability of 2 doses of capravirine. []
The difference between 2 doses of capravirine in terms of tolerability, efficacy, and pharmacokinetics []
The relationship of HIV resistance (genotype and phenotype) to virologic response. []
The immunologic response as determined by CD4 and CD8 absolute lymphocyte counts []
The population pharmacokinetics of capravirine and VIRACEPT []
The pharmacokinetics of potential drug-drug interactions. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female at least 18 years old
HIV RNA level >1000 copies/mL at screening
CD4 >50 cells/uL at screening
Patient is currently taking a regimen that includes an NNRTI plus 2 NRTIs for at least 28 days and is currently failing this regimen
Patient has adequate hematology tests (absolute neutrophil count >1000/uL, Platelets>75,000uL, hemoglobin 9g/L)
Patient has adequate renal function (serum creatinine of <1.5 upper limit of normal)
Patient has adequate liver function (AST, ALT, and bilirubin < 2.5 upper limit of normal)

Exclusion Criteria:

Previous use of protease inhibitors (except if patient has short duration of PI and was switched for tolerability reasons when viral load was <50 copies) This exception does not include Viracept
Women who are pregnant or lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Beverly Hills	California	United States	90211
2	Pfizer Investigational Site	Long Beach	California	United States	90813
3	Pfizer Investigational Site	Newport Beach	California	United States	92663
4	Pfizer Investigational Site	San Francisco	California	United States	94115
5	Pfizer Investigational Site	San Francisco	California	United States	94121
6	Pfizer Investigational Site	West Hollywood	California	United States	90069
7	Pfizer Investigational Site	Fort Lauderdale	Florida	United States	33311
8	Pfizer Investigational Site	Miami	Florida	United States	33137
9	Pfizer Investigational Site	Safety Harbor	Florida	United States	34695
10	Pfizer Investigational Site	Tampa	Florida	United States	33602
11	Pfizer Investigational Site	Atlanta	Georgia	United States	30339-3915
12	Pfizer Investigational Site	Jonesboro	Georgia	United States	30236
13	Pfizer Investigational Site	Tucker	Georgia	United States	30084
14	Pfizer Investigational Site	Chicago	Illinois	United States	60611
15	Pfizer Investigational Site	Wichita	Kansas	United States	67214
16	Pfizer Investigational Site	Jackson	Mississippi	United States	39202
17	Pfizer Investigational Site	Brooklyn	New York	United States	11203
18	Pfizer Investigational Site	New York	New York	United States	10003
19	Pfizer Investigational Site	Stony Brook	New York	United States	11794
20	Pfizer Investigational Site	Huntersville	North Carolina	United States	28078
21	Pfizer Investigational Site	Winston-Salem	North Carolina	United States	27157-1042
22	Pfizer Investigational Site	Akron	Ohio	United States	44304
23	Pfizer Investigational Site	Cincinnati	Ohio	United States	45267
24	Pfizer Investigational Site	Portland	Oregon	United States	97209
25	Pfizer Investigational Site	Portland	Oregon	United States	97210
26	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19107
27	Pfizer Investigational Site	Austin	Texas	United States	78705
28	Pfizer Investigational Site	Dallas	Texas	United States	75246
29	Pfizer Investigational Site	Galveston	Texas	United States	77555
30	Pfizer Investigational Site	Houston	Texas	United States	77009
31	Pfizer Investigational Site	Lyon	Cedex 02	France	69288
32	Pfizer Investigational Site	Paris	Cedex 10	France	74575
33	Pfizer Investigational Site	Lyon	Cedex 3	France	69437
34	Pfizer Investigational Site	Nantes		France	44035
35	Pfizer Investigational Site	Ulm	Bavaria	Germany	89070
36	Pfizer Investigational Site	Brescia		Italy	25123
37	Pfizer Investigational Site	Milano		Italy	20127
38	Pfizer Investigational Site	Milano		Italy	20157
39	Pfizer Investigational Site	Roma		Italy	00149
40	Pfizer Investigational Site	Cape Town		South Africa	7405
41	Pfizer Investigational Site	Cape Town		South Africa	7925
42	Pfizer Investigational Site	Johannesburg		South Africa	02198
43	Pfizer Investigational Site	Johannesburg		South Africa	2008
44	Pfizer Investigational Site	Johannesburg		South Africa	2193
45	Pfizer Investigational Site	Pietermaritzburg		South Africa	3201
46	Pfizer Investigational Site	Port Elizabeth		South Africa	6001
47	Pfizer Investigational Site	Pretoria North		South Africa	0182
48	Pfizer Investigational Site	Soweto		South Africa	2013
49	Pfizer Investigational Site	Baracaldo	Bilbao, Vizcaya	Spain	48903
50	Pfizer Investigational Site	Bilbao	Vizcaya	Spain	48903
51	Pfizer Investigational Site	Barcelona		Spain	08035
52	Pfizer Investigational Site	Cordoba		Spain	14004