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

NCT ID: NCT00002324

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Nevirapine

Intervention Type: DRUG

Zidovudine

Intervention Type: DRUG

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Locations

UCSD Treatment Ctr

San Diego, California, United States

Saint Francis Mem Hosp

San Francisco, California, United States

Wilmington Hosp

Wilmington, Delaware, United States

Community Research Initiative of South Florida

Coral Gables, Florida, United States

Goodgame Med Group

Maitland, Florida, United States

Univ of Kansas School of Medicine

Wichita, Kansas, United States

Chandler Med Ctr

Lexington, Kentucky, United States

Kansas City AIDS Research Consortium

Kansas City, Missouri, United States

Community Research Initiative on AIDS

New York, New York, United States

Med College of Ohio

Toledo, Ohio, United States

Associates Med and Mental Health

Tulsa, Oklahoma, United States

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States

Dr Alfred F Burnside Jr

Columbia, South Carolina, United States

Nelson-Tebedo Community Clinic

Dallas, Texas, United States

Houston Clinical Research Network

Houston, Texas, United States

Univ of Utah School of Medicine

Salt Lake City, Utah, United States

Infectious Disease Physicians Inc

Annandale, Virginia, United States

Richmond AIDS Consortium

Richmond, Virginia, United States

Countries

United States

References

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

Reference Type: BACKGROUND

Other Identifiers

1038

Identifier Type: -

Identifier Source: secondary_id

200C

Identifier Type: -

Identifier Source: org_study_id