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An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3) Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3) Clinical research trials and An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3) healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3). An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3) Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3) clinical trial. Participants typically obtain the most effective healthcare available for their An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3) condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3)  An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3)
An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3)
For Condition: HIV Infections
Status: Completed
Sponsor(s): Boehringer Ingelheim Pharmaceuticals ,
Synopsis: To assess the safety and tolerance of multiple oral doses of nevirapine in combination with zidovudine (AZT); to get information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine/AZT with multiple dosing; to characterize the pattern of virological activity in vivo (in humans) of nevirapine in combination with AZT; to determine whether development of resistance to either drug is slowed by the use of the combination. Drugs now used in treatment for patients with AIDS show some toxicity which limits their usefulness. In addition, with long-term treatment with AZT, there is evidence of virus resistance to the drug. Compounds that are more effective and less toxic than those in present use would be beneficial, especially if they are active against AZT-resistant viruses. Nevirapine has shown in vitro (test tube studies) activity in inhibiting HIV replication (reproduction). In vitro studies have shown that nevirapine and AZT work together to inhibit HIV replication.
Details: Drugs now used in treatment for patients with AIDS show some toxicity which limits their usefulness. In addition, with long-term treatment with AZT, there is evidence of virus resistance to the drug. Compounds that are more effective and less toxic than those in present use would be beneficial, especially if they are active against AZT-resistant viruses. Nevirapine has shown in vitro (test tube studies) activity in inhibiting HIV replication (reproduction). In vitro studies have shown that nevirapine and AZT work together to inhibit HIV replication. Groups of 10 patients are studied at each of three dose levels. Five patients at each dose level have less than 3 months of prior AZT treatment; five patients at each dose level have at least 12 months of previous AZT treatment and tolerated an AZT regimen of 600 mg/day (200 mg every 8 hours). At least 24 patient-weeks of treatment with the combination treatment must be completed without requiring dose interruption before the next dosage level can be started. All 30 patients must be enrolled at a lower dosage level before a higher dosage level is started. Patients begin treatment with AZT. 14 days later, patients begin treatment with nevirapine in addition to the AZT. After 24 weeks, patients have the option to continue long-term treatment with either nevirapine or standard treatment.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Included: Pneumocystis carinii pneumonia prophylaxis (other than sulfamethoxazole alone or in combination with other medications). - Antifungal prophylaxis with oral fluconazole or ketoconazole. - Antiviral prophylaxis with a maximum of 1 g/day oral acyclovir. Patients must have the following: - HIV infection. - Ability to voluntarily provide written informed consent prior to treatment. - Willing and able to follow protocol requirements. - Patients with nonvisceral Kaposi's sarcoma or with visceral Kaposi's sarcoma not requiring chemotherapy and/or irradiation may be included. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Radiographic evidence of chronic pulmonary disease. - Cytomegalovirus disease. - Toxoplasmosis encephalitis requiring suppressive therapy. - Mycobacteriosis requiring maintenance chemotherapy. - Visceral Kaposi's sarcoma requiring chemotherapy and/or irradiation. Concurrent Medication: Excluded: - Glucocorticoids and steroid hormones (including oral contraceptives). - Dicumarol, warfarin, and other anticoagulant medications. - Nitroglycerin. - Digitoxin. - Valproic acid. - Tolbutamide. - Doxycycline. - Chloramphenicol. - Isoniazid. - Antiepileptics (Phenobarbital and other barbiturates). - Sulfonamides. Excluded for up to 4 hours before and 4 hours after administration of drug 2: - Antacids. - Cimetidine. - Carafate. - Cholestyramine resin. - Alcohol and alcohol-containing substances. - Benzodiazepines (diazepam, triazolam). Patients with the following are excluded: - History of clinically important disease (defined as a disease that, in the opinion of the investigator, may either put the patient at risk because of participation in the study or a disease that may influence the results of the study or the patient's ability to participate in the study) other than HIV infection. - Malignancy other than Kaposi's sarcoma or limited cutaneous basal cell carcinoma. Prior Medication: Excluded within 4 weeks prior to administration of study drug 2: - Antiretroviral (other than zidovudine (AZT)), immunosuppressive, or cytotoxic drugs. - Glucocorticoids and steroid hormones (including oral contraceptives). - Dicumarol, warfarin, and other anticoagulant medications. - Nitroglycerin. - Digitoxin. - Valproic acid. - Tolbutamide. - Doxycycline. - Chloramphenicol Isoniazid. - Antiepileptics (Phenobarbital and other barbiturates). - Sulfonamides.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
SarahCheeseman, Study Chair,
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Massachusetts
Worcester, Massachusetts, 01655
United States
Cooper Green Hosp
Birmingham, Alabama, 35233
United States
Additional Information:
Study ID Numbers: ACTG 168; 00834
Study Start Date:
Record last reviewed: June 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000649
Other Hiv Infections Studies:
1. A Phase I Multicenter, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of Recombinant Vaccinia Virus Expressing the Envelope Glycoproteins of Human Immunodeficiency Virus
2. 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)
3. A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated with Anti-HIV Drugs
4. A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients
5. Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
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An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients with HIV Infection (CD4+ Cell Count < 400/mm3)
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