A Study to Compare Two Different Anti-HIV Drug Regimens

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000924

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

120

Enrollment

Locations

2.7

Patients Per Site

Study Details

Study Description

Brief Summary

This study compares 2 different anti-HIV drug regimens to determine which is the most effective in lowering the amount of HIV in the blood. The anti-HIV drugs used in this study are 2 protease inhibitors (nelfinavir and ritonavir), 2 nucleoside reverse transcriptase inhibitors (stavudine and didanosine), and 1 nonnucleoside reverse transcriptase inhibitor (nevirapine).

These drug combinations have been previously studied in adults, but there is limited information on how well they work in HIV-infected children. It is important to develop drug combinations which are effective at suppressing the HIV virus in children.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Nevirapine Drug: Stavudine Drug: Didanosine	Phase 2

Detailed Description

The use of combination therapy with 2 or more antiretroviral agents has been strongly supported by recent studies in both children and adults. However, as of yet, few combinations of antiretrovirals have been studied in large cohorts of stable HIV-1 infected, antiretroviral-experienced children. Evidence suggests that viral suppression may be more difficult to achieve in children. Therefore, it is important to develop new drug combinations which can maximally suppress plasma HIV-1 RNA concentrations in children.

Patients are stratified by prior antiretroviral treatment (zidovudine [ZDV]/lamivudine [3TC] versus d4T/other treatment) and by age (under 24 months versus 24 months and older). Patients are then randomized to 1 of 4 treatment groups.

Arm A1: ddI/NFV/RTV (for prior ZDV/3TC-treated patients). Arm A2: ddI/NFV/RTV (for prior d4T/other-treated patients). Arm B1: d4T/NFV/NVP (for prior ZDV/3TC-treated patients). Arm B2: d4T/NFV/NVP (for prior d4T/other-treated patients). Treatment is administered for 48 weeks. At Weeks 2, 4, and then every 4 weeks thereafter, patients undergo physical examinations, and blood samples are drawn to measure viral load. [AS PER AMENDMENT 4/27/00: Patients in Arms A1 and A2 may continue to receive medication for an additional 24 weeks. While on the treatment extension, patients must continue their current schedule for study drug administration and completion of study visits. Patients in Arms A1 and A2 who have reached Week 44 participate in an enteric-coated ddI pharmacokinetic study as part of this 24-week extension. Patients who were enrolled in Arms A1 or A2 and who were taken off study after reaching Week 48 may be re-entered onto the study at Week 52 regardless of the number of weeks they have been off study.]

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase II Randomized, Multicenter Protocol Evaluating Two Antiretroviral Regimens Containing Combinations of Protease Inhibitors, NRTIs, and an NNRTI

Actual Study Completion Date :

Jun 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Months to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients may be eligible for this study if they:

Are between 4 months and 21 years of age (consent of parent or guardian required if under 18).
Are HIV-positive.
Have a viral level of at least 4,000 copies/ml.
Have a CD4 cell count of at least 750 (under 12 months of age), at least 500 (1 to 5 years of age), or at least 200 (6 years of age or older) cells/mm3 within the past 4 months or a CD4 percent of 15 percent or higher within the past 4 months.
Have received the same continuous antiretroviral therapy for the past 16 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have an active opportunistic and/or serious bacterial infection.
Have been diagnosed with a malignancy.
Have received prior treatment with certain antiretroviral medications.
Are pregnant or breast-feeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham - Pediatric	Birmingham	Alabama	United States	35233
2	Univ of South Alabama	Mobile	Alabama	United States	36604
3	Long Beach Memorial (Pediatric)	Long Beach	California	United States	90801
4	Los Angeles County - USC Med Ctr	Los Angeles	California	United States	90033
5	Harbor - UCLA Med Ctr / UCLA School of Medicine	Los Angeles	California	United States	905022004
6	Children's Hosp of Oakland	Oakland	California	United States	946091809
7	UCSF / Moffitt Hosp - Pediatric	San Francisco	California	United States	941430105
8	Howard Univ Hosp	Washington	District of Columbia	United States	20060
9	North Broward Hosp District	Fort Lauderdale	Florida	United States	33311
10	Univ of Florida Gainesville	Gainesville	Florida	United States	32610
11	Univ of Miami (Pediatric)	Miami	Florida	United States	33161
12	Emory Univ Hosp / Pediatrics	Atlanta	Georgia	United States	30306
13	Cook County Hosp	Chicago	Illinois	United States	60612
14	Chicago Children's Memorial Hosp	Chicago	Illinois	United States	606143394
15	Univ of Chicago Children's Hosp	Chicago	Illinois	United States	606371470
16	Tulane Univ / Charity Hosp of New Orleans	New Orleans	Louisiana	United States	701122699
17	Earl K Long Early Intervention Clinic	New Orleans	Louisiana	United States	70112
18	Univ of Maryland at Baltimore / Univ Med Ctr	Baltimore	Maryland	United States	21201
19	Johns Hopkins Hosp - Pediatric	Baltimore	Maryland	United States	212874933
20	Children's Hosp of Boston	Boston	Massachusetts	United States	021155724
21	Baystate Med Ctr of Springfield	Springfield	Massachusetts	United States	01199
22	Univ of Massachusetts Med School	Worcester	Massachusetts	United States	016550001
23	Children's Hosp of Michigan	Detroit	Michigan	United States	48201
24	Univ of Medicine & Dentistry of New Jersey / Univ Hosp	Newark	New Jersey	United States	071032714
25	Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl	Newark	New Jersey	United States	07103
26	Bronx Lebanon Hosp Ctr	Bronx	New York	United States	10457
27	Bronx Municipal Hosp Ctr/Jacobi Med Ctr	Bronx	New York	United States	10461
28	North Shore Univ Hosp	Great Neck	New York	United States	11021
29	Schneider Children's Hosp	New Hyde Park	New York	United States	11040
30	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
31	Metropolitan Hosp Ctr	New York	New York	United States	10029
32	Columbia Presbyterian Med Ctr	New York	New York	United States	10032
33	Incarnation Children's Ctr / Columbia Presbyterian Med Ctr	New York	New York	United States	10032
34	Harlem Hosp Ctr	New York	New York	United States	10037
35	State Univ of New York at Stony Brook	Stony Brook	New York	United States	117948111
36	SUNY Health Sciences Ctr at Syracuse / Pediatrics	Syracuse	New York	United States	13210
37	Duke Univ Med Ctr	Durham	North Carolina	United States	277103499
38	Med Univ of South Carolina	Charleston	South Carolina	United States	294253312
39	Saint Jude Children's Research Hosp of Memphis	Memphis	Tennessee	United States	381052794
40	Children's Med Ctr of Dallas	Dallas	Texas	United States	75235
41	Children's Hosp of the King's Daughters	Norfolk	Virginia	United States	23507
42	Med College of Virginia	Richmond	Virginia	United States	23219
43	Ramon Ruiz Arnau Univ Hosp / Pediatrics	Bayamon		Puerto Rico	00956
44	Univ of Puerto Rico / Univ Children's Hosp AIDS	San Juan		Puerto Rico	009365067
45	San Juan City Hosp	San Juan		Puerto Rico	009367344