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ACTG Salvage Therapy Trials

GMHC Treatment Issues; Vol 13, No. 1 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

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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