Abstract
Objective: To compare the clinical efficacy and tolerance of didanosine (ddl) monotherapy with low-dose zidovudine/didanosine (AZT/ddl) therapy among HIV-infected patients previously treated with AZT. Methods: A randomized controlled trial was carried out of ddl 400 mg daily versus AZT/ddl 300/200 mg daily among patients with CD4 cell counts ≤ 350 mm3 and prior AZT treatment for at least 16 weeks. Fifty eight patients received ddl monotherapy and 66 combined treatment. Results: Patients were similar with respect to demographic, clinical and laboratory characteristics, and prior AZT treatment. Median duration of follow-up was 17.3 months. In the ddl group, 20 patients (34%) discontinued treatment because of toxicity, compared to 19 (29%) in the AZT/ddl group (p = 0.38). There was no statistically significant difference in CD4 change between the two groups. In the ddl group, 16 patients (28%) developed a clinical endpoint (death or AIDS-defining opportunistic infection), compared to 33 (50%) in the combined therapy group (relative risk 1.8; 95% confidence interval 1.1~2.9; p = 0.01). Conclusions: For fairly advanced AZT-pretreated patients, monotherapy with ddl was clinically and statistically superior to the low-dose AZT/ddl combination in preventing AIDS-defining illness and death. When access to drugs is limited, e.g. in under-resourced countries, combining available drugs and reducing dosage may be less effective than a single drug at the conventional dosage.
| Original language | English |
|---|---|
| Pages (from-to) | 629-633 |
| Number of pages | 5 |
| Journal | Clinical Microbiology and Infection |
| Volume | 3 |
| Issue number | 6 |
| Publication status | Published - 1997 |
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Keywords
- AIDS
- Antiretroviral
- Combination therapy
- Didanosine
- Drug dosage
- HIV
- Randomized trial
- Zidovudine
ASJC Scopus subject areas
- Microbiology (medical)
- Microbiology
Cite this
Low doses of zidovudine plus didanosine are less effective than higher doses of didanosine monotherapy : A randomized trial in patients pretreated with zidovudine. / Sudre, Philippe; Chave, Jean Philippe; Ruef, Christian; Iten, Anne; Bucher, Heiner C.; Vernazza, Pietro L.; Furrer, Hansjakob; Bernasconi, Enos; Ceserani, Norberto; Battegay, Manuel; Von Overbeck, Jan; Cassis, Ignazio; Lazzarin, Adriano; Gabriel, Victor; Hirschel, Bernard J.
In: Clinical Microbiology and Infection, Vol. 3, No. 6, 1997, p. 629-633.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Low doses of zidovudine plus didanosine are less effective than higher doses of didanosine monotherapy
T2 - A randomized trial in patients pretreated with zidovudine
AU - Sudre, Philippe
AU - Chave, Jean Philippe
AU - Ruef, Christian
AU - Iten, Anne
AU - Bucher, Heiner C.
AU - Vernazza, Pietro L.
AU - Furrer, Hansjakob
AU - Bernasconi, Enos
AU - Ceserani, Norberto
AU - Battegay, Manuel
AU - Von Overbeck, Jan
AU - Cassis, Ignazio
AU - Lazzarin, Adriano
AU - Gabriel, Victor
AU - Hirschel, Bernard J.
PY - 1997
Y1 - 1997
N2 - Objective: To compare the clinical efficacy and tolerance of didanosine (ddl) monotherapy with low-dose zidovudine/didanosine (AZT/ddl) therapy among HIV-infected patients previously treated with AZT. Methods: A randomized controlled trial was carried out of ddl 400 mg daily versus AZT/ddl 300/200 mg daily among patients with CD4 cell counts ≤ 350 mm3 and prior AZT treatment for at least 16 weeks. Fifty eight patients received ddl monotherapy and 66 combined treatment. Results: Patients were similar with respect to demographic, clinical and laboratory characteristics, and prior AZT treatment. Median duration of follow-up was 17.3 months. In the ddl group, 20 patients (34%) discontinued treatment because of toxicity, compared to 19 (29%) in the AZT/ddl group (p = 0.38). There was no statistically significant difference in CD4 change between the two groups. In the ddl group, 16 patients (28%) developed a clinical endpoint (death or AIDS-defining opportunistic infection), compared to 33 (50%) in the combined therapy group (relative risk 1.8; 95% confidence interval 1.1~2.9; p = 0.01). Conclusions: For fairly advanced AZT-pretreated patients, monotherapy with ddl was clinically and statistically superior to the low-dose AZT/ddl combination in preventing AIDS-defining illness and death. When access to drugs is limited, e.g. in under-resourced countries, combining available drugs and reducing dosage may be less effective than a single drug at the conventional dosage.
AB - Objective: To compare the clinical efficacy and tolerance of didanosine (ddl) monotherapy with low-dose zidovudine/didanosine (AZT/ddl) therapy among HIV-infected patients previously treated with AZT. Methods: A randomized controlled trial was carried out of ddl 400 mg daily versus AZT/ddl 300/200 mg daily among patients with CD4 cell counts ≤ 350 mm3 and prior AZT treatment for at least 16 weeks. Fifty eight patients received ddl monotherapy and 66 combined treatment. Results: Patients were similar with respect to demographic, clinical and laboratory characteristics, and prior AZT treatment. Median duration of follow-up was 17.3 months. In the ddl group, 20 patients (34%) discontinued treatment because of toxicity, compared to 19 (29%) in the AZT/ddl group (p = 0.38). There was no statistically significant difference in CD4 change between the two groups. In the ddl group, 16 patients (28%) developed a clinical endpoint (death or AIDS-defining opportunistic infection), compared to 33 (50%) in the combined therapy group (relative risk 1.8; 95% confidence interval 1.1~2.9; p = 0.01). Conclusions: For fairly advanced AZT-pretreated patients, monotherapy with ddl was clinically and statistically superior to the low-dose AZT/ddl combination in preventing AIDS-defining illness and death. When access to drugs is limited, e.g. in under-resourced countries, combining available drugs and reducing dosage may be less effective than a single drug at the conventional dosage.
KW - AIDS
KW - Antiretroviral
KW - Combination therapy
KW - Didanosine
KW - Drug dosage
KW - HIV
KW - Randomized trial
KW - Zidovudine
UR - http://www.scopus.com/inward/record.url?scp=6844265582&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=6844265582&partnerID=8YFLogxK
M3 - Article
VL - 3
SP - 629
EP - 633
JO - Clinical Microbiology and Infection
JF - Clinical Microbiology and Infection
SN - 1198-743X
IS - 6
ER -