drugset / Trial / NCT00004578
ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
Timeline
- Start
- 1997-11
- Primary completion
- 2005-04
- Completion
- 2005-04
Publications
- Background Murphy R, King M, Brun S, Orth K, Hicks C, Eron J, Thommes J, Gulick R, Thompson M, White C, Benson C, Hammer S, Kessler H, Bertz R, Hsu A, Kempf D, Sun E, Japour A. ABT-378/ritonavir therapy in antiretroviral-naive HIV-I infected patients for 24 weeks. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:69 (abstract no 15)
- Background Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9. doi: 10.1097/00002030-200101050-00002.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lopinavir | Other / unclassified | 200 mg | Oral |
| Comparator | Lopinavir | Other / unclassified | 400 mg | Oral |
| Comparator | Ritonavir | Other / unclassified | 100 mg | Oral |
| Comparator | Ritonavir | Other / unclassified | 200 mg | Oral |
| Comparator | Lamivudine | Other / unclassified | 150 mg | — |
| Comparator | Stavudine | Other / unclassified | 40 mg | — |