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Home > "E" Clinical Trials Conditions > Evaluation of Patients Who Have Not Had Success with Zidovudine  Evaluation of Patients Who Have Not Had Success with Zidovudine
Evaluation of Patients Who Have Not Had Success with Zidovudine
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,Glaxo Wellcome
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. Exclusion Criteria 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.
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
CoreyL, Study Chair,
Kaiser Permanente Franklin Med Ctr
Denver, Colorado, 80262
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
Chicago, Illinois, 60611
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Additional Information:
Study ID Numbers: ACTG 194;
Study Start Date:
Record last reviewed: July 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001025
Other Hiv Infections Studies:
1. Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex
2. A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy
3. A Randomized Trial of the Efficacy and Safety of a Strategy of Starting with Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals with CD4+ Cell Counts Less than or Equal to 200/mm3
4. Use of a Test that Evaluates How the Body Handles Insulin and Glucose
5. Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Evaluation of Patients Who Have Not Had Success with Zidovudine
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