Evaluation of Patients Who Have Not Had Success With Zidovudine
Completed · Phase 2
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00001025
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 120
- Expected to finish
- 1995-05-01
- Last updated by the study team
- 2021-11-01
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- Allowed:
- Chemoprophylaxis against Pneumocystis carinii pneumonia (PCP), Mycobacterium tuberculosis, or Herpes simplex virus, or against other opportunistic infections as indicated.
- Corticosteroids for no longer than 21 days (only as part of PCP therapy).
- Erythropoietin and G-CSF.
- Patients must have:
- Documented HIV-seropositivity.
- CD4 count 100 - 300 cells/mm3.
- Prior continuous AZT dose = or > 300 mg/day for 1 year or longer.
- Prior Medication: Required:
- AZT for at least 1 year prior to study entry.
You may not qualify if…
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Medical contraindication or is considered noncompliant in the opinion of the investigator.
- Peripheral neuropathy = or > grade 2.
- Concurrent Medication:
- Excluded:
- Anti-HIV agents other than study drugs.
- Biologic response modifiers (other than erythropoietin or G-CSF).
- Systemic cytotoxic chemotherapy.
- Regularly prescribed medications (such as antipyretics, analgesics, allergy medications) that are associated with an increased risk of pancreatitis, peripheral neuropathy, or bone marrow suppression.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis, gout, or uric acid nephropathy.
- Prior Medication:
- Excluded:
- Other antiretrovirals besides AZT.
- ddI or ddC for more than 30 days within the past year or any time within 3 months prior to study entry.
- Acute therapy for an infection or other medical illness within 14 days prior to study entry.
Where it is running
- Univ of Alabama at Birmingham — Birmingham, Alabama, United States
- San Francisco Gen Hosp — San Francisco, California, 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
- 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
- Northwestern Univ Med School — Chicago, Illinois, United States
- Cook County Hosp — Chicago, Illinois, United States
- Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
- Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
- Univ of Minnesota — Minneapolis, Minnesota, United States
- Univ of Nebraska Med Ctr — Omaha, Nebraska, United States
- SUNY / Health Sciences Ctr at Brooklyn — Brooklyn, New York, United States
- SUNY / Erie County Med Ctr at Buffalo — Buffalo, New York, United States
- Univ of Rochester Medical Center — Rochester, New York, United States
- SUNY / State Univ of New York — Syracuse, New York, United States
- Univ of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.