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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT00002324

Collaborator

(none)

250

Enrollment

Locations

13.9

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Nevirapine Drug: Zidovudine	Phase 2

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.

Study Design

Study Type:

Interventional

Masking:

Double

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Treatment Ctr	San Diego	California	United States	92103
2	Saint Francis Mem Hosp	San Francisco	California	United States	94109
3	Wilmington Hosp	Wilmington	Delaware	United States	19801
4	Community Research Initiative of South Florida	Coral Gables	Florida	United States	33146
5	Goodgame Med Group	Maitland	Florida	United States	32751
6	Univ of Kansas School of Medicine	Wichita	Kansas	United States	67214
7	Chandler Med Ctr	Lexington	Kentucky	United States	405360084
8	Kansas City AIDS Research Consortium	Kansas City	Missouri	United States	641082792
9	Community Research Initiative on AIDS	New York	New York	United States	10001
10	Med College of Ohio	Toledo	Ohio	United States	43699
11	Associates Med and Mental Health	Tulsa	Oklahoma	United States	74114
12	Philadelphia FIGHT	Philadelphia	Pennsylvania	United States	19107
13	Dr Alfred F Burnside Jr	Columbia	South Carolina	United States	29204
14	Nelson-Tebedo Community Clinic	Dallas	Texas	United States	75219
15	Houston Clinical Research Network	Houston	Texas	United States	77006
16	Univ of Utah School of Medicine	Salt Lake City	Utah	United States	84132
17	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22203
18	Richmond AIDS Consortium	Richmond	Virginia	United States	23219