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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002323
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 2002
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Nevirapine
Drug: Zidovudine

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 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

Resource links provided by NLM:


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

Estimated Enrollment: 60
Detailed Description:

Patients receive combination nevirapine/AZT or AZT alone. Patients are evaluated for virologic and immunologic activity at 3 and 6 months.

  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 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.

  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: NCT00002323

Locations
United States, California
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, United States, 946021018
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Missouri
Washington Univ School of Medicine
St. Louis, Missouri, United States, 63108
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 775550882
Sponsors and Collaborators
Boehringer Ingelheim
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002323     History of Changes
Other Study ID Numbers: 200B, BIPI 1037
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
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 18, 2014