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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002046 |
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: | Treatment, Dose Comparison |
| Official Title: | A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Treatment:
Allowed:
Patients with the following are excluded:
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.
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.
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:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Active drug or alcohol abuse.
Contacts and Locations| United States, Arizona | |
| Univ of Arizona / Health Science Ctr | |
| Tucson, Arizona, United States, 85724 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| 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 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77550 | |
More Information
| Study ID Numbers: | 014G, 18 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002046 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
|
Antimetabolites Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Zidovudine Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors |