|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |
| Brief Title † | A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past |
| Official Title † | A Randomized, Double-Blind Multicenter Trial to Compare the Safety and Efficacy of Lamivudine (3TC; GR109714X) Monotherapy Versus Zidovudine (AZT) Monotherapy Versus 3TC Administered With AZT in the Treatment of HIV-1 Infected Patients Who Are AZT Naive (< 4 Weeks) With CD4 Cell Counts of 200-500 Cells/mm3 |
| Brief Summary | To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients. PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy. |
| Detailed Description | Patients are randomized to one of four treatment arms: 3TC alone, AZT alone, low-dose 3TC plus AZT, or high-dose 3TC plus AZT. Patients receive treatment for 32 weeks, with possible extension to 52 weeks. PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates. |
| Study Phase | Phase III |
| Study Type † | Interventional |
| Study Design † | Treatment, Double-Blind, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | HIV Infections |
| Intervention † | Drug: Lamivudine Drug: Zidovudine |
| MEDLINE PMIDs | 9030391, 8853730 |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 320 |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria Patients must have:
Exclusion Criteria Patients with the following prior condition are excluded: History of intolerance to AZT. Prior Medication: Excluded:
|
| Gender | Both |
| Ages | 12 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States, Canada, Puerto Rico |
| Administrative Information Fields | |
| NCT ID † | NCT00002320 |
| Organization ID | 129B |
| Secondary IDs †† | NUCA 3001 |
| Study Sponsor † | Glaxo Wellcome |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | May 1994 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | December 8, 2005 |