The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002324
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 2002
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Nevirapine
Drug: Zidovudine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 250
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002324

Locations
United States, California
UCSD Treatment Ctr
San Diego, California, United States, 92103
Saint Francis Mem Hosp
San Francisco, California, United States, 94109
United States, Delaware
Wilmington Hosp
Wilmington, Delaware, United States, 19801
United States, Florida
Community Research Initiative of South Florida
Coral Gables, Florida, United States, 33146
Goodgame Med Group
Maitland, Florida, United States, 32751
United States, Kansas
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 67214
United States, Kentucky
Chandler Med Ctr
Lexington, Kentucky, United States, 405360084
United States, Missouri
Kansas City AIDS Research Consortium
Kansas City, Missouri, United States, 641082792
United States, New York
Community Research Initiative on AIDS
New York, New York, United States, 10001
United States, Ohio
Med College of Ohio
Toledo, Ohio, United States, 43699
United States, Oklahoma
Associates Med and Mental Health
Tulsa, Oklahoma, United States, 74114
United States, Pennsylvania
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Dr Alfred F Burnside Jr
Columbia, South Carolina, United States, 29204
United States, Texas
Nelson-Tebedo Community Clinic
Dallas, Texas, United States, 75219
Houston Clinical Research Network
Houston, Texas, United States, 77006
United States, Utah
Univ of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22203
Richmond AIDS Consortium
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Boehringer Ingelheim
  More Information

Publications:
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

ClinicalTrials.gov Identifier: NCT00002324     History of Changes
Other Study ID Numbers: 200C, 1038
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
AIDS-Related Complex
Zidovudine
Nevirapine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Nevirapine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 27, 2014