Evaluation of Patients Who Have Not Had Success With Zidovudine
- Conditions
- HIV Infections
- Registration Number
- NCT00001025
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
SUNY / Health Sciences Ctr at Brooklyn
🇺🇸Brooklyn, New York, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Kaiser Permanente Franklin Med Ctr
🇺🇸Denver, Colorado, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
🇺🇸Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
SUNY / State Univ of New York
🇺🇸Syracuse, New York, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Univ of Nebraska Med Ctr
🇺🇸Omaha, Nebraska, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
🇺🇸San Jose, California, United States
San Mateo AIDS Program / Stanford Univ
🇺🇸Stanford, California, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States