| November 2, 1999 |
| April 2, 2008 |
| November 1997 |
| April 2005 (final data collection date for primary outcome measure) |
- Proportion of subjects with viral load below the limit of quantitation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Time to loss of virologic response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
|
| Same as current |
| Complete list of historical versions of study NCT00004578 on ClinicalTrials.gov Archive Site |
| Proportion of subjects with viral load below the limit of quantitation at each visit [ Time Frame: At each visit ] [ Designated as safety issue: No ] |
| Same as current |
| |
| ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects |
| Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients |
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects. |
| |
| Phase I, Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| HIV Infections |
- Drug: Lopinavir/Ritonavir
- Drug: Lamivudine
- Drug: Stavudine
|
- Active Comparator: Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added.
- Active Comparator: Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.
|
| 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. |
| |
| Completed |
| 100 |
| April 2005 |
| April 2005 (final data collection date for primary outcome measure) |
Inclusion Criteria
- HIV-1 positive
- antiretroviral-adult males
- non-pregnant
- non-lactating females at least 18-years old with plasma HIV-1 RNA > 5000 copies/mL, who were not acutely ill
Exclusion Criteria
History of:
- prior antiretroviral therapy
- significant drug hypersensitivity
- psychiatric illness that precludes compliance
- an active substance abuser
- positive test results for drug abuse
- abnormal lab test results (hemoglobin, absolute neutrophil count, platelet count, SGPT/AST or SGPT/ALT, creatinine, fasting triglycerides, significant abnormal ECG results
- pregnancy or lactating female
- received another investigational drug within 28 days of study initiation
- unlikely to comply or unsuitable candidate in the opinion of the investigator
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00004578 |
| George Hanna, MD, Anti-viral Global Project Head, Abbott |
| 285A, M97-720 |
| Abbott |
|
| Study Director: |
George Hanna, MD |
Abbott |
|
|
| Abbott |
| April 2008 |
