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Evaluation of Patients Who Have Not Had Success With Zidovudine

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Zidovudine (Drug); Didanosine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Corey L, Study Chair
Cavert W, Study Chair
Coombs R, Study Chair

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.

Clinical Details

Official title: A Study to Evaluate the Short-Term Clinical and Virologic Significance of Zidovudine Resistance

Study design: Primary Purpose: Treatment

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.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States

San Francisco Gen Hosp, San Francisco, California 941102859, United States

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose, California 951282699, United States

San Mateo AIDS Program / Stanford Univ, Stanford, California 943055107, United States

Kaiser Permanente Franklin Med Ctr, Denver, Colorado 80262, United States

Univ of Colorado Health Sciences Ctr, Denver, Colorado 80262, United States

Children's Mem Hosp Family Cln / Northwestern Univ Med Schl, Chicago, Illinois 60611, United States

Cook County Hosp, Chicago, Illinois 60612, United States

Northwestern Univ Med School, Chicago, Illinois 60611, United States

Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States

Baystate Med Ctr of Springfield, Springfield, Massachusetts 01199, United States

Univ of Minnesota, Minneapolis, Minnesota 55455, United States

Univ of Nebraska Med Ctr, Omaha, Nebraska 681985130, United States

SUNY / Health Sciences Ctr at Brooklyn, Brooklyn, New York 112032098, United States

SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York 14215, United States

Univ of Rochester Medical Center, Rochester, New York 14642, United States

SUNY / State Univ of New York, Syracuse, New York 13210, United States

Univ of Washington, Seattle, Washington 981224304, United States

Additional Information

Click here for more information about Zidovudine

Click here for more information about Didanosine

Related publications:

Cavert W, Coombs RW, Kuritzkes D, Grimes J, Stein D, Rojo W, Beatty C, Winters M, Corey L. Baseline zidovudine (ZDV) susceptibility, codon 215 mutation, viral load and syncytium-inducting characteristics(SI) of HIV isolates from ACTG protocol 194. Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:137

Reichelderfer PS, Coombs RW. Multifactorial analysis of the inverse relationship between viral load and CD4+ cell count. Int Conf AIDS. 1996 Jul 7-12;11(2):277 (abstract no ThB4148)


Last updated: March 28, 2012

Page last updated: August 23, 2015

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