ACTG Salvage Therapy Trials
From Gay Men's Health Crisis
January 1999
A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!
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
Advertisement>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
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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
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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
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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
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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
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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
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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
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Abbreviations
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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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Back to the GMHC Treatment Issues January 1999 contents page.
A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!
 This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.
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