Evaluation of Patients Who Have Not Had Success With Zidovudine
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00001025 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: March 29, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Zidovudine Drug: Didanosine | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Enrollment : | 120 participants |
Primary Purpose: | Treatment |
Official Title: | A Study to Evaluate the Short-Term Clinical and Virologic Significance of Zidovudine Resistance |
Actual Study Completion Date : | May 1995 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001025
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium | |
San Jose, California, United States, 951282699 | |
San Mateo AIDS Program / Stanford Univ | |
Stanford, California, United States, 943055107 | |
United States, Colorado | |
Kaiser Permanente Franklin Med Ctr | |
Denver, Colorado, United States, 80262 | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Illinois | |
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl | |
Chicago, Illinois, United States, 60611 | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
Cook County Hosp | |
Chicago, Illinois, United States, 60612 | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
United States, Massachusetts | |
Baystate Med Ctr of Springfield | |
Springfield, Massachusetts, United States, 01199 | |
United States, Minnesota | |
Univ of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Nebraska | |
Univ of Nebraska Med Ctr | |
Omaha, Nebraska, United States, 681985130 | |
United States, New York | |
SUNY / Health Sciences Ctr at Brooklyn | |
Brooklyn, New York, United States, 112032098 | |
SUNY / Erie County Med Ctr at Buffalo | |
Buffalo, New York, United States, 14215 | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
SUNY / State Univ of New York | |
Syracuse, New York, United States, 13210 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 981224304 |
Study Chair: | Corey L | ||
Study Chair: | Cavert W | ||
Study Chair: | Coombs R |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001025 History of Changes |
Other Study ID Numbers: |
ACTG 194 11170 ( Registry Identifier: DAIDS ES Registry Number ) |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | March 29, 2012 |
Last Verified: | March 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Virus Replication Didanosine Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Zidovudine |
Didanosine Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |