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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2007-004379-20-IT
Date of registration:	08/01/2009
Prospective Registration:	Yes
Primary sponsor:	PFIZER
Public title:	A PHASE 2B MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE TRIAL OF UK-453,061, IN COMBINATION WITH TENOFOVIR DF AND EMTRICITABINE VERSUS EFAVIRENZ IN COMBINATION WITH TENOFOVIR DF AND EMTRICITABINE FOR THE TREATMENT OF ANTIRETROVIRAL-NAIVE HIV-1 INFECTED SUBJECTS - ND
Scientific title:	A PHASE 2B MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE TRIAL OF UK-453,061, IN COMBINATION WITH TENOFOVIR DF AND EMTRICITABINE VERSUS EFAVIRENZ IN COMBINATION WITH TENOFOVIR DF AND EMTRICITABINE FOR THE TREATMENT OF ANTIRETROVIRAL-NAIVE HIV-1 INFECTED SUBJECTS - ND
Date of first enrolment:	21/01/2009
Target sample size:	189
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004379-20
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no
Phase:

Countries of recruitment
Italy	Poland	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
1. Evidence of a personally signed and dated informed consent document indicating that the
subject (or a legally acceptable representative) has been informed of all pertinent aspects
of the study.
2. Male or female at least 18 years of age available for a follow-up period of at least
96 weeks.
3. HIV-1 RNA viral load of ≥1,000 copies/mL measured by the Roche COBAS
AmpliPrep/COBAS TaqMan HIV-1 test at the screening visit.
4. Negative urine pregnancy test at the Day 1 visit, prior to receiving the first dose of study
medication, for Women of Child Bearing Potential (WOCBP).
NOTE: WOCBP includes any female who has experienced menarche and who has not
undergone successful surgical sterilization or is not post-menopausal (ie, no menstrual
periods for at least 2 years). Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products (intrauterine devices; barrier methods: eg,
condom or diaphragm with spermicide) to prevent pregnancy, who are practicing abstinence,
or who have a partner that is sterile (eg, vasectomy), should be considered to be of child
bearing potential.
5. Effective barrier contraception for WOCBP and males. In addition, WOCBP must use
another acceptable method of contraception for the duration of the study and for 28 days
after leaving the study. Acceptable contraception includes, but is not limited to, oral,
implanted or injectable hormone therapy and intrauterine devices.
6. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Suspected or documented active, untreated HIV-1 related OI or other condition requiring
acute therapy at the time of randomization. Subjects on a stable (>30 days) secondary OI
prophylaxis regimen or chronic treatment are eligible for the study, as are subjects on a
primary OI prophylaxis regimen of any duration, except Trimethoprim-sulfamethoxazole.
Subjects on primary, secondary prophylaxis and therapy with Trimethoprim-sulfamethoxazole
must be in therapy >60 days.
2. Subjects on therapy for Hepatitis B.
3. Subjects with acute Hepatitis B and/or C within 30 days of randomization.
4. Subjects with Hepatitis C on therapy with interferon and/or ribavirin for <60 days.
5. Absolute CD4+ cell count <200 cells/mm3.
6. Treatment for an active OI, or unexplained temperature >38.5 C, for 7 consecutive days
within 30 days prior to randomization.
7. Prior treatment with efavirenz, emtricitabine, or tenofovir DF, or with any other antiretroviral
therapy for more than 14 cumulative days at any time.
8. Active alcohol or substance abuse sufficient, in the investigator?s judgment, to prevent
adherence to study medication and/or follow-up.
9. Lactating women, or planned pregnancy during the trial period.
10. Suspected acute HIV-1 infection.
11. Initiation of therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or
cytotoxic agent within 60 days prior to randomization or the expected need for such therapy
during the study period.
12. Malignancy requiring parenteral therapy that must be continued during the trial.
13. Documented or suspected pancreatitis within 30 days prior to randomization.
14. Renal insufficiency defined as a serum creatinine greater than 3 times the upper limit of
normal or a creatinine clearance of less than 50 mL/min.
15. Total bilirubin greater than ≥1.5 times the upper limit of normal.
16. AST and/or ALT greater than 3 times the upper limit of normal.
17. Male subjects with a baseline QT of >450 msec and female subjects with a baseline QT of
>470 msec.
18. Subjects with cardiac events (MI, bypass surgery, angioplasty) within 6 months of
randomization.
19. Cirrhosis of the liver.
20. Absolute neutrophil count ≤750 cells/mm3.
21. Platelet count ≤50,000 cells/mm3.
22. Hemoglobin ≤7 g/dL.
23. Clinically significant malabsorption syndrome (eg, ≥6 loose stools per day for at least
7 consecutive days) within 30 days prior to randomization.
24. Presence of gross hematuria or grade 4 proteinuria at the time of screening.
25. Inability to tolerate oral medication.
26. Concomitant therapy with other investigational agents within 30 days prior to enrollment into
the study.
27. Participation in other investigational studies within 30 days prior to study start and/or during
study participation. 28. Use of the following CYP3A4/UGT inhibitors/inducers/substrates are prohibited: barbiturates
(eg, phenobarbital), carbamazepine, oxycarbazepine, phenytoin, glucocorticoids (short-term
[≤14 days] burst therapy will be allowed], rifampin/rifampicin, rifabutin, St. John?s Wort,
voriconazole, ketoconazole, itraconazole, astemizole, ergot derivatives, midazolam,
triazolam, bepridil, cisapride, pimozide, clarithromycin, nefazadone, and telithromycin.
Prohibited medications must be discontinued at least 14 days prior to randomization.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Treatment of HIV-1 infection in combination with other agents in antiretroviral-naive subjects.
MedDRA version: 9.1 Level: LLT Classification code 10000811 Term: Acute infection with HIV

Intervention(s)

Product Code: UK-453,061
Pharmaceutical Form: Tablet
CAS Number: 473921-12-9
Current Sponsor code: UK-453,061
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Sustiva
Pharmaceutical Form: Tablet
INN or Proposed INN: Efavirenz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Truvada
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tenofovir DF
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
INN or Proposed INN: emtricitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Main Objective: The primary objective is to assess the efficacy of UK-453,061 when used in
combination with tenofovir DF/emtricitabine, as measured by percentage of
subjects with HIV-1 RNA <48 copies/mL at 48 weeks.

Primary end point(s): Percentage of subjects with HIV-1 RNA <48 copies/mL at 48 weeks.

Secondary Objective: To assess efficacy as measured by percentage of subjects with HIV-1 RNA <48
copies/mL and <400 copies/mL.
Change from baseline in log10 transformed HIV-1 RNA levels.
To assess the pharmacokinetics (PK) and pharmacokinetic/pharmacodynamic
(PK/PD) relationship of UK-453,061.
To assess pharmacokinetic parameters of UK-453,061 AUC24, Cmax and C24h (PK
sub-study).

Secondary Outcome(s)

Secondary ID(s)

2007-004379-20-GB

A5271015

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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