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A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nevirapine
Zidovudine
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Zidovudine, Nevirapine

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 infection. CD4 count 200-500 cells/mm3. No prior AIDS. No history of or active HIV-related thrush, vaginal candidiasis, zoster (shingles), excessive weight loss, persistent fever, or diarrhea. Tolerated 500-600 mg AZT daily for at least 4 months but no more than 12 months immediately prior to study entry. Consent of parent or guardian if less than 18 years of age. NOTE: Patients may not co-enroll in another protocol involving other investigational drugs or biologics. 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 study compliance. Concurrent Medication: Excluded: 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. Biologic response modifiers (alpha interferon, IL-2, immune modulators). Any investigational drugs other than study drugs. Patients with the following prior condition are excluded: History of clinically important disease other than HIV infection, that may put patient at risk because of participation in this 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. Biologic response modifiers (alpha interferon, IL-2, immune modulators). Required: AZT at 500-600 mg/day for at least 4 months but no more than 12 months immediately preceding study entry. Chronic use of alcohol or drugs sufficient to impair study compliance.

Sites / Locations

  • Highland Gen Hosp / San Francisco Gen Hosp
  • Northwestern Univ Med School
  • Johns Hopkins Hosp
  • Washington Univ School of Medicine
  • Univ TX Galveston Med Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00002323
Brief Title
A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell
Official Title
A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cells/mm3
Study Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage. SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two regimens.
Detailed Description
Patients receive combination nevirapine/AZT or AZT alone. Patients are evaluated for virologic and immunologic activity at 3 and 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Zidovudine, Nevirapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nevirapine
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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 infection. CD4 count 200-500 cells/mm3. No prior AIDS. No history of or active HIV-related thrush, vaginal candidiasis, zoster (shingles), excessive weight loss, persistent fever, or diarrhea. Tolerated 500-600 mg AZT daily for at least 4 months but no more than 12 months immediately prior to study entry. Consent of parent or guardian if less than 18 years of age. NOTE: Patients may not co-enroll in another protocol involving other investigational drugs or biologics. 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 study compliance. Concurrent Medication: Excluded: 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. Biologic response modifiers (alpha interferon, IL-2, immune modulators). Any investigational drugs other than study drugs. Patients with the following prior condition are excluded: History of clinically important disease other than HIV infection, that may put patient at risk because of participation in this 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. Biologic response modifiers (alpha interferon, IL-2, immune modulators). Required: AZT at 500-600 mg/day for at least 4 months but no more than 12 months immediately preceding study entry. Chronic use of alcohol or drugs sufficient to impair study compliance.
Facility Information:
Facility Name
Highland Gen Hosp / San Francisco Gen Hosp
City
Oakland
State/Province
California
ZIP/Postal Code
946021018
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Washington Univ School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550882
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell

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