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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002324
• Other study ID #: 200C
• Secondary ID: 1038
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: August 2002
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Nevirapine

• Zidovudine

Locations

Country	Name	City	State
United States	Infectious Disease Physicians Inc	Annandale	Virginia
United States	Dr Alfred F Burnside Jr	Columbia	South Carolina
United States	Community Research Initiative of South Florida	Coral Gables	Florida
United States	Nelson-Tebedo Community Clinic	Dallas	Texas
United States	Houston Clinical Research Network	Houston	Texas
United States	Kansas City AIDS Research Consortium	Kansas City	Missouri
United States	Chandler Med Ctr	Lexington	Kentucky
United States	Goodgame Med Group	Maitland	Florida
United States	Community Research Initiative on AIDS	New York	New York
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	Richmond AIDS Consortium	Richmond	Virginia
United States	Univ of Utah School of Medicine	Salt Lake City	Utah
United States	UCSD Treatment Ctr	San Diego	California
United States	Saint Francis Mem Hosp	San Francisco	California
United States	Med College of Ohio	Toledo	Ohio
United States	Associates Med and Mental Health	Tulsa	Oklahoma
United States	Univ of Kansas School of Medicine	Wichita	Kansas
United States	Wilmington Hosp	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

References & Publications (1)

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