A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002046
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1990
  Purpose

To evaluate the pharmacokinetics of Retrovir (AZT) administered orally as 1 of 3 doses in the treatment of patients with severe clinical and laboratory manifestations of HIV infection. To compare the safety and tolerance of AZT administered 2, 3, and 6 x daily to these patients.


Condition Intervention
HIV Infections
Drug: Zidovudine

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Treatment:

Allowed:

  • Electron beam therapy to an area of less than 100 cm2.

Patients with the following are excluded:

  • Any immediately life-threatening infection or medical condition present at the time of study entry.
  • Any active opportunistic or other infection requiring chronic therapy present at the time of study entry.
  • Patients with Pneumocystis carinii pneumonia (PCP) may be randomized to study medication following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have fever < 39 degrees C for at least 48 hours; oxygen (on room air)

    = or > 60 mm, and arterial / alveolar gradient = or < 30 mm.

  • Kaposi's sarcoma, lymphoma, or other tumor likely to require cytotoxic chemotherapy.

Seropositive for HIV antibody documented by any federally licensed ELISA.

Patients must have ability to give informed consent and advanced HIV disease defined as:

- History of Pneumocystis carinii pneumonia (PCP) with histologic verification within 4 months of study entry.

OR History of other opportunistic infection included in the CDC surveillance definition of AIDS (stage IV-C-1), diagnosed within 4 months of entry, but not requiring chronic suppressive therapy, and a CD4+ cell count < 200 cells/mm3.

OR AIDS related complex (ARC) only those patients with a CD4+ count < 200 cells/mm3 and documentation of at least two signs or symptoms from the list below. One sign or symptom must be weight loss or candidiasis as described.

  • Unexplained weight loss > 10 percent or = or > 15 lbs within the previous 4 months; with low weight at entry.
  • History of mucocutaneous oral candidiasis (by culture or potassium hydroxide KOH smear).
  • Fever > 38 degrees C, without documented infectious cause present, persisting > 1 month.
  • Oral hairy leukoplakia.
  • Unexplained night sweats, persisting > 1 month.
  • Herpes zoster infection within 3 months of entry.
  • Chronic diarrhea of unknown infectious etiology persisting > 1 month after 3 samples have been done eliminating ova, parasites, Cryptosporidia, Mycobacterium avium intracellulare, cytomegalovirus (CMV), and other pathogens associated with diarrheal disease in AIDS patients.

Negative Venereal Disease Research Laboratory (VDRL) or Rapid Plasma Reagent (RPR) or, if positive and verified by Fluorescent Treponemal Antibody Absorption (FTAABS), documented history of treatment for syphilis. If FTAABS is positive, but treatment history is not available, the patient may be entered 3 or more days following the initiation of appropriate chemotherapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Chronic herpes virus infection.
  • Fever > 39 degrees C at study entry.
  • Known hypersensitivity to lactate and/or gelatin.
  • Kaposi's sarcoma, lymphoma, or other tumor likely to require cytotoxic chemotherapy.
  • Impaired renal function.
  • AIDS dementia complex.

Concurrent Medication:

Excluded:

  • Drugs which cause significant bone marrow suppression.
  • Rifampin or rifampin derivatives.
  • Drugs which cause significant nephrotoxicity or hepatotoxicity.
  • Antiretroviral agents, including ribavirin, dideoxycytidine, dideoxyadenosine, didanosine, foscarnet, dextran sulfate, and AL-721.
  • Acyclovir therapy of more than 21 days duration.

Concurrent Treatment:

Excluded:

  • Radiation therapy (with the exception of electron beam therapy to an area of less than 100 cm2).
  • Experimental therapy.
  • Cytolytic chemotherapy.

Prior Medication:

Excluded:

  • Acyclovir therapy of more than 21 days duration.
  • Zidovudine (AZT).
  • Excluded within 2 weeks of study entry:
  • Drugs which cause significant bone marrow suppression.
  • Rifampin or rifampin derivatives.
  • Drugs which cause significant nephrotoxicity or hepatotoxicity.
  • Immunomodulating agents, including pharmacologic doses of steroids for > 10 days.
  • Excluded within 4 weeks of study entry:
  • Interferon.
  • Isoprinosine.
  • IL-2.
  • Excluded within 8 weeks of study entry:
  • Antiretroviral agents, including ribavirin, dideoxycytidine, dideoxyadenosine, didanosine, foscarnet, dextran sulfate, and AL-721.

Prior Treatment:

Excluded:

  • Radiation therapy (with the exception of electron beam therapy to an area of less than 100 cm2).
  • Experimental therapy.
  • Cytolytic chemotherapy.

Active drug or alcohol abuse.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002046

Locations
United States, Arizona
Univ of Arizona / Health Science Ctr
Tucson, Arizona, United States, 85724
United States, Illinois
Cook County Hosp
Chicago, Illinois, United States, 60612
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21205
United States, Missouri
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
United States, New Mexico
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, United States, 87131
United States, New York
Northshore Hosp / Cornell Univ
Manhasset, New York, United States, 11030
United States, Pennsylvania
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002046     History of Changes
Other Study ID Numbers: 014G, 18
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 29, 2014