Reductions in HIV-1 disease progression for zidovudine/lamivudine relative to control treatments
| Autor: | John Bartlett, Christine Katlama, Schlomo Staszewski, Hugh McDade, Judy Johnson, Andrew M. Hill, W. Sawyer, Joseph J. Eron |
|---|---|
| Rok vydání: | 1997 |
| Předmět: |
Adult
Male Oncology medicine.medical_specialty Adolescent Anti-HIV Agents Immunology HIV Infections Asymptomatic Zalcitabine Zidovudine Double-Blind Method immune system diseases Internal medicine medicine Humans Immunology and Allergy Sida biology business.industry Incidence (epidemiology) virus diseases Lamivudine Middle Aged biology.organism_classification United States Confidence interval Infectious Diseases Relative risk Disease Progression HIV-1 Female Centers for Disease Control and Prevention U.S medicine.symptom business medicine.drug |
| Zdroj: | AIDS. 11:477-483 |
| ISSN: | 0269-9370 |
| DOI: | 10.1097/00002030-199704000-00011 |
| Popis: | Objectives: Four randomized double-blind trials have demonstrated that zidovudine/lamivudine (ZDV/3TC) reduces HIV RNA and raises CD4 counts relative to control treatments [ZDV or ZDV/zalcitabine (ddC)]. A meta-analysis of the clinical events in these trials was conducted to determine whether treatment with ZDV/3TC was also associated with a clinical benefit. Design: The four trials, ZDV/3TC versus ZDV (NUCA3001, NUCB3001, NUCB3002) or versus ZDV/ddC (NUCA3002), were run concurrently, using the same doses of ZDV and 3TC. Setting: Investigational sites in Europe and North America. Patients: The trials recruited 972 HIV-1-positive, male and female patients aged ≥18 years, with CD4 counts of 100-500 cells x 10 6 /l. Two trials were for ZDV-naive patients and two were for ZDV pre-treated patients. Main outcome measures: Progression to first new Centers for Disease Control and Prevention (CDC) B or C event was compared between all ZDV/3TC arms and all control (ZDV, ZDV/ddC) arms. Results: A total of 118 patients progressed to a first new CDC B/C event during the four trials, while 28 progressed to a new CDC C event. Meta-analysis of the trials showed a 49% reduction in progression to new CDC B/C events (relative risk, 0.509; 9.5% confidence interval, 0.365-0.710; P < 0.0001) and a 66% reduction in progression to new CDC C events (relative risk, 0.344; 95% confidence interval, 0.169-0.700; P= 0.003) for the ZDV/3TC patients relative to the control patients. Reductions in progression to CDC B/C disease were seen in subgroups of naive and pre-treated patients, those with high and low CD4 counts and symptomatic and asymptomatic patients. Conclusions: ZDV/3TC combination treatment delays the progression of CDC B/C disease compared with control treatments. In view of the low incidence of CDC C events, the results for progression to CDC C disease should be interpreted with caution. |
| Databáze: | OpenAIRE |
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