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The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease 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 The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease Clinical research trials and The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease 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 The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease. The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease 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 The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease clinical trial. Participants typically obtain the most effective healthcare available for their The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease 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 > "T" Clinical Trials Conditions > The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease  The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease
The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease
For Condition: HIV Infections
Status: Completed
Sponsor(s): Boehringer Ingelheim Pharmaceuticals ,
Synopsis: PRIMARY: To compare the effect of nevirapine versus placebo alone or in combination with zidovudine (AZT) on CD4 T-cell count and percentage after 3 and 6 months of treatment. To evaluate the safety and tolerance of nevirapine alone or in combination with AZT. SECONDARY: To compare the effects of the various treatment combinations on virologic and immunologic markers.
Details: In Part I, patients who have had prior AZT therapy receive either nevirapine or placebo in combination with AZT. In Part II, patients who are nucleoside naive receive either nevirapine or matching placebo. After 6 months, patients receive open-label nevirapine.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - PCP prophylaxis (trimethoprim-sulfamethoxazole, dapsone, or aerosolized pentamidine), at the discretion of the investigator. - Antifungal prophylaxis with oral fluconazole or ketoconazole. - Antiviral prophylaxis for herpes simplex virus with <= 1000 mg/day oral acyclovir. - Dilantin for prevention and treatment of seizures. Patients must have: - Asymptomatic HIV-1 infection, with positive serum antibody to HIV-1 as determined by ELISA or Western blot. - CD4 count 200-500 cells/mm3 within 4-28 days prior to study entry. - No conditions indicative of AIDS. - None of the constitutional symptoms that are specifically excluded. - Prior AZT for 3-24 months (amended 04/04/94) immediately prior to study entry (Part I) OR no prior AZT (Part II). - Consent of parent or guardian if less than 18 years of age. NOTE: - Co-enrollment in a protocol involving another investigational drug or biologic is not permitted. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Malignancy other than limited cutaneous basal cell carcinoma. - Psychiatric condition sufficient to impair compliance with protocol requirements. Concurrent Medication: Excluded: - Investigational drugs other than study drugs. - Systemic glucocorticoids and steroid hormones. - Dicumarol, warfarin, and other anticoagulant medications. - Cimetidine. - Tolbutamide. - Doxycycline. - Chloramphenicol. - Phenobarbital and other barbiturates. - Foscarnet. - Erythromycin. - Amoxicillin-clavulanate (Augmentin). - Ticarcillin clavulanate (Timentin). - Biologic response modifiers (alpha interferon, IL-2, immune modulators). Patients with the following condition are excluded: History of other clinically important disease (i.e., one that precludes participation in the study). Prior Medication: Excluded: - Antiretroviral medications other than AZT. Excluded within 4 weeks prior to study entry: - Immunosuppressive or cytotoxic drugs or other experimental drugs. - Systemic glucocorticoids and steroid hormones. - Dicumarol, warfarin, and other anticoagulant medications. - Cimetidine. - Tolbutamide. - Doxycycline. - Chloramphenicol. - Phenobarbital and other barbiturates. - Foscarnet. - Erythromycin. - Amoxicillin-clavulanate (Augmentin). - Ticarcillin clavulanate (Timentin). - Biologic response modifiers (alpha interferon, IL-2, immune modulators). Required (for patients in Part I): - Prior AZT at 500-600 mg daily for at least 3 months but not more than 24 months immediately prior to study entry. Chronic use of alcohol or drugs sufficient to impair compliance with protocol requirements.
Total Enrollment: 250
Location and Contact Information:
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Associates Med and Mental Health
Tulsa, Oklahoma, 74114
United States
Saint Francis Mem Hosp
San Francisco, California, 94109
United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
United States
Dr Alfred F Burnside Jr
Columbia, South Carolina, 29204
United States
Richmond AIDS Consortium
Richmond, Virginia, 23219
United States
Houston Clinical Research Network
Houston, Texas, 77006
United States
UCSD Treatment Ctr
San Diego, California, 92103
United States
Community Research Initiative on AIDS
New York City, New York, 10001
United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 641082792
United States
Goodgame Med Group
Maitland, Florida, 32751
United States
Med College of Ohio
Toledo, Ohio, 43699
United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
United States
Nelson-Tebedo Community Clinic
Dallas, Texas, 75219
United States
Wilmington Hosp
Wilmington, Delaware, 19801
United States
Chandler Med Ctr
Lexington, Kentucky, 405360084
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
United States
Additional Information:
Study ID Numbers: 200C; 1038
Study Start Date:
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002324
Other Hiv Infections Studies:
1. A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
2. A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients
3. The Safety and Effectiveness of Ritonavir in the Treatment of HIV-Related Kaposi's Sarcoma
4. A Treatment IND for 566C80 Therapy of Pneumocystis carinii Pneumonia
5. A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.
Related Studies:
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The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease
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