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ACTG Salvage Therapy Trials

January 1999

The AIDS Clinical Trials Group, an offshoot of the National Institutes of Health, is conducting a series of second-line treatment studies in volunteers with significant viral loads despite nucleoside analog and, sometimes, protease inhibitor therapy. These are the largest such trials so far. The variety of second-line regimens tested in each trial is rather complicated. Regimens and the results now available, most of which were just presented at the 6th Conference on Retroviruses and Opportunistic Infections, are described in the table below.

Trial: ACTG 359

Participants

>6 months prior indinavir and viral load between 2,000 and 200,000.

N = 300 (N = 42 for the drug interaction substudy)


Salvage Regimens

A. SQV/RTV/DLV

B. SQV/RTV/ADV

C. SQV/RTV/DLV/ADV

D. SQV/NFV/DLV

E. SQV/NFV/ADV

F. SQV/NFV/DLV/ADV


Outcome So Far

DLV increased total drug levels of SQV/RTV or SQV/NFV. ADV unexpectedly decreased DLV levels, causing a decrease in SQV


Comments

SQV, RTV, DLV, NFV all affect and are eliminated by cytochrome P450 liver metabolism. ADV is excreted by the kidney. Virologic and immunologic response data available this spring.


Source: 6th Retrovirus Conference, abstract 365

Trial: ACTG 364

Participants

Long-time NA experience (participants rolled over from ACTG 175 to ACTG 302/303 to ACTG 364).

Median entry VL = 21,000

Mean entry CD4 = 388

N = 195


Salvage Regimens

2 nucleoside analogs, at least one new (d4T/3TC, d4T/ddI, ddI/3TC) + EFV, NFV, or EFV + NFV


Outcome So Far

% with VL <500, week 40-48:

2 NAs/EFV: 60%
2 NAs/NFV: 35%
2 NAs/NFV/EFV: 74%


Comments

Difference between nelfinavir arm and the efavirenz-containing arms was statistically significant but unexplained. Adherence issues?


Source: 6th Retrovirus Conference, abstract 489

Trial: ACTG 368

Participants

>2 months 3TC + either AZT or d4T and CD4 <250 (mostly rolled over from ACTG 320).

Mean entry VL = 16,000

Mean entry CD4 = 153

N = 283


Salvage Regimens

A: IDV q8h/EFV ± ABC

B: IDV q12h/EFV ± ABC


Outcome So Far

ABC vs. placebo, % with VL <500, week 16:
78% vs. 73%

IDV q8h vs. q12h, % viral load <500, week 48:
85% vs. 68%


Comments

ABC vs. placebo: difference was nonsignificant.

IDV q8h vs. q12h: q8h significantly better.


Source: 6th Retrovirus Conference, abstract LB15

Trial: ACTG 370

Rolled over from ACTG 306 with viral load >500.


Participants

Prior time on two NAs: 24 to 36 months

N = 105


Salvage Regimens

ddI/3TC or d4T/3TC switched to AZT/3TC/IDV or AZT/DLV/IDV

AZT/3TC switched to d4T/DLV/IDV


Outcome So Far

% with VL <200, week 16:

AZT/3TC/IDV - 65%
AZT/DLV/IDV - 80%
d4T/DLV/IDV - 80%


Comments

No significant difference between arms, though trend to improved outcome by switching 3TC to DLV.


Source: 6th Retrovirus Conference, abstract 488

Trial: ACTG 372B

Participants

AZT/3TC/IDV failure (ACTG 320 roll over).

Median entry VL = 39,000

Median entry CD4 = 196

N = 94


Salvage Regimens

I. ABC/EFV/ADV/NFV

II. ABC/EFV/ADV

III. NAs/EFV/ADV/NFV

IV. NAs/EFV/ADV


Outcome So Far

ABC vs. NAs, % with VL <500, week 16:
33% vs. 30%

NFV vs. placebo, % with VL <500, week 16:
43% vs. 21%


Comments

ABC vs. NAs: difference was nonsignificant.

NFV was significantly better than placebo.


Source: 6th Retrovirus Conference, abstract 490

Trial: ACTG 398

Participants

VL >1,000 after >16 weeks of SQV, IDV, NFV or RTV

N = 460


Salvage Regimens

APV/ABC/EFV/ADV + SQV, IDV, NFV or placebo


Outcome So Far

No data yet


Comments

Recruiting

18 month follow-up

Trial: ACTG 400

Participants

VL >1,000 after >16 weeks NFV

No prior NVP, DLV, EFV

N = 300


Salvage Regimens

A. RTV/SQV/EFV/2 NAs

B. IDV/EFV/2 NAs

C. APV/EFV/2 NAs

D. IDV/APV/EFV/2 NAs

2 NAs = ddI or 3TC + AZT or d4T


Outcome So Far

No data yet


Comments

Recruiting

18 month follow-up

Abbreviations
ABC - abacavir
ADV - adefovir
APV - amprenavir
DLV - delavirdine
EFV - efavirenz
IDV - indinavir
NA - nucleoside analog
NFV - nelfinavir
NVP - nevirapine
RTV - ritonavir
SQV - saquinavir
N - number of trial participants
PK - phramacokinetics
q8h - every eight hours
q12h - every 12 hours
VL - viral load


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