|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 2, 1999 | ||||||||||||
| Last Updated Date | August 6, 2008 | ||||||||||||
| Start Date ICMJE | |||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||
| Change History | Complete list of historical versions of study NCT00001025 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Evaluation of Patients Who Have Not Had Success With Zidovudine | ||||||||||||
| Official Title ICMJE | A Study to Evaluate the Short-Term Clinical and Virologic Significance of Zidovudine Resistance | ||||||||||||
| Brief Summary | To determine the relationship of viral susceptibility to zidovudine (AZT) and baseline viral load (as determined by plasma viremia and quantitative endpoint dilution). To determine the relationship between viral load and susceptibility during different antiretroviral therapy strategies. To correlate measures of viral load and short term clinical and laboratory markers (such as weight, CD4 count, p24 antigenemia, and beta2 microglobulin) on the different therapy arms. High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical significance of in vitro AZT resistance, it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors. |
||||||||||||
| Detailed Description | High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical significance of in vitro AZT resistance, it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors. One hundred-twenty patients who have been receiving AZT for at least 1 year are randomized to 1) continue with AZT, 2) switch to treatment with didanosine at 1 of 2 doses, or 3) receive both AZT and ddI. Treatment is given for 16 weeks, with a possible extension to 32 weeks. Patients are followed at weeks 2, 4, 8, 12, and 16. For analysis purposes only, patients are stratified according to degree of susceptibility of HIV isolates to AZT. |
||||||||||||
| Study Phase | Phase II | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment | ||||||||||||
| Condition ICMJE | HIV Infections | ||||||||||||
| Intervention ICMJE |
|
||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||||||
| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 120 | ||||||||||||
| Completion Date | |||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Patients must have:
Prior Medication: Required:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded:
Concurrent Medication: Excluded:
Concurrent Treatment: Excluded:
Patients with the following prior conditions are excluded:
Prior Medication: Excluded:
|
||||||||||||
| Gender | Both | ||||||||||||
| Ages | 12 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00001025 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | ACTG 194 | ||||||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
| Collaborators ICMJE |
|
||||||||||||
| Investigators ICMJE |
|
||||||||||||
| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
| Verification Date | July 1995 | ||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||