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Table H-1. Design Features of Individual Trials

 

R89-001

R90-001

R91-010

H3X-PPPC

Phase

I/II

Dose escalation

I/II

Dose escalation

I/II

Dose escalation

I/II

Treatment

Randomized control

None

None

None

None

IND

Oclassen 33,638

Oclassen 34,973

Oclassen 34,973

Lilly

No. of centers

2

3

1

1

Investigators

Richman Corey

Richman Corey Straus

Hoofnagle

Hoofnagle

Performance sites

U. of Cal. S.D.

U. of Wash., Seattle

U. of Cal., S.D.

U. of Wash., Seattle

NIH, Bethesda

NIH, Bethesda

NIH, Bethesda

Drug

FIAC

FIAU

FIAU

FIAU

Treatment period

28 days

14 days

28 days

168 days

1st dose

17 Nov 89

9 Oct 90

13 Apr 92

24 Mar 93

Last dose

25 May 90

29 Jun 92

10 Sep 92

28 Jun 93

No. enrolled

12

43

24

15

Enrollment period

188 days

628 days

150 days

95 days

Enrollment rate

15.67 days

6.05 days

6.25 days

6.33 days

No. of Deaths

4

4

1

5

Prior FIAC/FIAU

No

No

No

Yes (11)

Study pop.

AIDS (2)

AIDS+CMV (10)

HIV (13)

HIV+HVB (30)

Compensated HVB

Compensated HVB

Treatment and follow-up

35 days

42 days

168 days

168 days

Dose

Low

0.6 mg/kg/day

0.1 mg/kg/day

0.05 mg/kg/day

0.10 mg/kg/day

High

1.0 mg/kg/day

1.7 mg/kg/day

0.5 mg/kg/day

0.25 mg/kg/day

Project titles:

R89-001: Efficacy and safety of oral FIAC in AIDS patients with cytomegalovirus infection: A dose-ranging study.

R90-001: The tolerance of HIV-infected patients with herpes-group infections to oral doses of FIAU.

R91-010: FIAU oral dose-ranging study in patients with compensated chronic hepatitis B.

H3X-MC-PPPC: FIAU redosing for the treatment of patients with compensated chronic hepatitis B: a six-month course.



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