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Home > "A" Clinical Trials Conditions > A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC  A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC
A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, 87131
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21205
United States
Northshore Hosp / Cornell Univ
Manhasset, New York, 11030
United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
United States
Additional Information:
Study ID Numbers: 014G; 18
Study Start Date:
Record last reviewed: May 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002046
Other Hiv Infections Studies:
1. A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo
2. A Study of Amprenavir in Patients with Protease Inhibitor-Related Complications
3. Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
4. Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load.
5. An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Manhasset Clinical Trials
A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC
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