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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
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, AIDS-Related Complex, 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-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.

Sites / Locations

  • UCSD Treatment Ctr
  • Saint Francis Mem Hosp
  • Wilmington Hosp
  • Community Research Initiative of South Florida
  • Goodgame Med Group
  • Univ of Kansas School of Medicine
  • Chandler Med Ctr
  • Kansas City AIDS Research Consortium
  • Community Research Initiative on AIDS
  • Med College of Ohio
  • Associates Med and Mental Health
  • Philadelphia FIGHT
  • Dr Alfred F Burnside Jr
  • Nelson-Tebedo Community Clinic
  • Houston Clinical Research Network
  • Univ of Utah School of Medicine
  • Infectious Disease Physicians Inc
  • Richmond AIDS Consortium

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
NCT00002324
Brief Title
The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease
Official Title
A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Activity, Safety, and Tolerance of 1) 400 Mg Nevirapine in Combination With 500-600 Mg Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 3-24 Months of Prior Zidovudine Therapy and 200-500 CD4 Cells/mm3 and 2) 400 Mg Nevirapine Versus Nevirapine Placebo in Asymptomatic HIV-1 Nucleoside Naive Patients With 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 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.
Detailed Description
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.

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, AIDS-Related Complex, Zidovudine, Nevirapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
250 (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-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.
Facility Information:
Facility Name
UCSD Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Saint Francis Mem Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Wilmington Hosp
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Facility Name
Community Research Initiative of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Goodgame Med Group
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Chandler Med Ctr
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
405360084
Country
United States
Facility Name
Kansas City AIDS Research Consortium
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
641082792
Country
United States
Facility Name
Community Research Initiative on AIDS
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Med College of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43699
Country
United States
Facility Name
Associates Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Dr Alfred F Burnside Jr
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Nelson-Tebedo Community Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Univ of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
Richmond AIDS Consortium
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Pollard R . Surrogate marker response to NVP/ZDV or ZDV in a blinded clinical trial: correlation to changes in HIV isolate phenotypic susceptibility to NVP and ZDV. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:113
Results Reference
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Learn more about this trial

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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