A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00000902
• Collaborator: (none)
• Enrollment: 217
• Locations: 62
• Patients Per Site: 3.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment.

Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by giving patients anti-HIV drugs which affect the virus at various stages of development. Changing the medications may enhance the results of treatment.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Ritonavir; Drug: Nelfinavir mesylate; Drug: Nevirapine; Drug: Lamivudine; Drug: Stavudine; Drug: Zidovudine; Drug: Zalcitabine; Drug: Didanosine	Phase 1

Detailed Description

The Master RAD Protocol is based on the concept that optimal suppression of viral load in vivo will be achieved in patients with rapidly progressing or advanced HIV disease (RAD) using antiretroviral combinations inhibiting viral replication at distinct sites of action. Antiretroviral combinations are chosen with the hypothesis that simultaneous change to as many new agents as possible is necessary to maximally reduce plasma viral load.

In this open-label, multicenter study patients are randomized into 1 of 4 groups based on prior antiretroviral experience. Each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors (stavudine, lamivudine, zidovudine, didanosine, zalcitabine) plus nevirapine (NVP), nelfinavir (NFV), or ritonavir (RTV). Patients must be naive to at least 2 of the 4 drugs in the regimen and at least 1 of the novel drugs must be NVP, NFV, or RTV.

Prior to randomization to a NFV- or RTV-containing regimen, patients are stratified by HIV RNA (greater than or equal to 50,000 or less than 50,000) and must able to receive 2 or more novel drugs.

Study Design

• Study Type: Interventional
• Primary Purpose: Treatment
• Official Title: RAD-1: A Phase I/II Antiretroviral Management Algorithm for Pediatric Subjects of Four-Drug Combination Therapies Based on Prior Antiretroviral Experience
• Actual Study Completion Date: Apr 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

Your child may be eligible for this study if he or she:

• Is HIV-positive.

• Is between the ages of 6 months and 21 years (consent of parent or guardian required if under 18).

• Has an HIV blood level above 50,000 copies/mL on 2 consecutive occasions, while taking anti-HIV therapy.

• Has advanced HIV disease or disease progression while receiving 8 weeks or more of continuous unchanged anti-HIV therapy.

• Is able to receive at least one of the following: RTV, NVP, or NFV.

Exclusion Criteria

Your child will not be eligible for this study if he or she:

• Is receiving treatment for a serious bacterial, viral, or opportunistic (HIV-associated) infection within 14 days prior to study entry.

• Has a history of pancreatitis or peripheral neuropathy.

• Has cancer requiring chemotherapy.

• Is allergic to the study medications.

• Is taking certain medications.

• Is pregnant.

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	UCSD Med Ctr / Pediatrics / Clinical Sciences	La Jolla	California	United States	920930672
4	Long Beach Memorial (Pediatric)	Long Beach	California	United States	90801
5	Los Angeles County - USC Med Ctr	Los Angeles	California	United States	90033
6	Cedars Sinai / UCLA Med Ctr	Los Angeles	California	United States	900481804
7	Harbor - UCLA Med Ctr / UCLA School of Medicine	Los Angeles	California	United States	905022004
8	Children's Hosp of Oakland	Oakland	California	United States	946091809
9	UCSF / Moffitt Hosp - Pediatric	San Francisco	California	United States	941430105
10	Children's Hosp of Denver	Denver	Colorado	United States	802181088
11	Connecticut Children's Med Ctr	Farmington	Connecticut	United States	060303805
12	Yale Univ Med School	New Haven	Connecticut	United States	06504
13	Howard Univ Hosp	Washington	District of Columbia	United States	20060
14	North Broward Hosp District	Fort Lauderdale	Florida	United States	33311
15	Univ of Florida Health Science Ctr / Pediatrics	Jacksonville	Florida	United States	32209
16	Univ of Miami (Pediatric)	Miami	Florida	United States	33161
17	Emory Univ Hosp / Pediatrics	Atlanta	Georgia	United States	30306
18	Med College of Georgia	Augusta	Georgia	United States	30912
19	The Med Ctr Inc	Columbus	Georgia	United States	31901
20	Cook County Hosp	Chicago	Illinois	United States	60612
21	Univ of Illinois College of Medicine / Pediatrics	Chicago	Illinois	United States	60612
22	Chicago Children's Memorial Hosp	Chicago	Illinois	United States	606143394
23	Tulane Univ / Charity Hosp of New Orleans	New Orleans	Louisiana	United States	701122699
24	Univ of Maryland at Baltimore / Univ Med Ctr	Baltimore	Maryland	United States	21201
25	Johns Hopkins Hosp - Pediatric	Baltimore	Maryland	United States	212874933
26	Children's Hosp of Boston	Boston	Massachusetts	United States	021155724
27	Boston City Hosp / Pediatrics	Boston	Massachusetts	United States	02118
28	Baystate Med Ctr of Springfield	Springfield	Massachusetts	United States	01199
29	Univ of Massachusetts Med School	Worcester	Massachusetts	United States	016550001
30	Univ of Mississippi Med Ctr	Jackson	Mississippi	United States	39213
31	UMDNJ - Robert Wood Johnson Med School / Pediatrics	New Brunswick	New Jersey	United States	089030019
32	Univ of Medicine & Dentistry of New Jersey / Univ Hosp	Newark	New Jersey	United States	071032714
33	Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl	Newark	New Jersey	United States	07103
34	Children's Hosp at Albany Med Ctr	Albany	New York	United States	12208
35	Bronx Lebanon Hosp Ctr	Bronx	New York	United States	10457
36	SUNY - Brooklyn	Brooklyn	New York	United States	11203
37	North Shore Univ Hosp	Great Neck	New York	United States	11021
38	Schneider Children's Hosp	New Hyde Park	New York	United States	11040
39	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
40	Cornell Univ Med College	New York	New York	United States	10021
41	Metropolitan Hosp Ctr	New York	New York	United States	10029
42	Columbia Presbyterian Med Ctr	New York	New York	United States	10032
43	Incarnation Children's Ctr / Columbia Presbyterian Med Ctr	New York	New York	United States	10032
44	Harlem Hosp Ctr	New York	New York	United States	10037
45	Univ of Rochester Med Ctr	Rochester	New York	United States	146420001
46	State Univ of New York at Stony Brook	Stony Brook	New York	United States	117948111
47	SUNY Health Sciences Ctr at Syracuse / Pediatrics	Syracuse	New York	United States	13210
48	Duke Univ Med Ctr	Durham	North Carolina	United States	277103499
49	Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr	Durham	North Carolina	United States	27710
50	Columbus Children's Hosp	Columbus	Ohio	United States	432052696
51	Children's Hosp of Philadelphia	Philadelphia	Pennsylvania	United States	191044318
52	Saint Christopher's Hosp for Children	Philadelphia	Pennsylvania	United States	191341095
53	Med Univ of South Carolina	Charleston	South Carolina	United States	294253312
54	Saint Jude Children's Research Hosp of Memphis	Memphis	Tennessee	United States	381052794
55	Vanderbilt Univ Med Ctr	Nashville	Tennessee	United States	372322581
56	Children's Med Ctr of Dallas	Dallas	Texas	United States	75235
57	Texas Children's Hosp / Baylor Univ	Houston	Texas	United States	77030
58	Children's Hosp of the King's Daughters	Norfolk	Virginia	United States	23507
59	Med College of Virginia	Richmond	Virginia	United States	23219
60	Ramon Ruiz Arnau Univ Hosp / Pediatrics	Bayamon		Puerto Rico	00956
61	Univ of Puerto Rico / Univ Children's Hosp AIDS	San Juan		Puerto Rico	009365067
62	San Juan City Hosp	San Juan		Puerto Rico	009367344

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Andrea Kovacs,
• Study Chair: Sandra Burchett,

Study Documents (Full-Text)

None provided.

More Information

Publications

• Frenkel LM, Burchett SK, Aldrovandi GM, Carey V, Oyomopito R, Mahalanibis M, Decker D, Kovacs A. HIV-1 reverse transcriptase (RT) M184V/I improves the rate of suppression of viral replication by salvage therapy. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 463)
• Kovacs A, Burchett S, Khoury M, Carey V, Pahwa S, McIntosh K, Oyomopito R, Smith E, Mofenson L. Virologic and immunologic responses in children with advanced HIV disease on a new HAART regimen (PACTG 366). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 684)
• Weinberg A, Kovacs A, Pahwa S, Carey V, Oyomopito R, Mofenson L, Khoury M, Zimmer B, Burchett S. HIV-infected children on HAART reconstitute tetanus-specific T cell responses without booster vaccination. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 688)
• Weinberg A, Pahwa S, Oyomopito R, Carey VJ, Zimmer B, Mofenson L, Kovacs A, Burchett SK; Pediatric AIDS Clinical Trials Group 366 Team. Antimicrobial-specific cell-mediated immune reconstitution in children with advanced human immunodeficiency virus infection receiving highly active antiretroviral therapy. Clin Infect Dis. 2004 Jul 1;39(1):107-14. Epub 2004 Jun 14.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00000902
• Other Study ID Numbers: ACTG 366; 11329
• First Posted: Aug 31, 2001
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Zalcitabine; Didanosine; Drug Therapy, Combination; Zidovudine; Nevirapine; Stavudine; Ritonavir; Lamivudine; RNA, Viral; Anti-HIV Agents; Nelfinavir
• Additional relevant MeSH terms: HIV Infections; Ritonavir; Nelfinavir; Lamivudine; Zidovudine; Nevirapine; Didanosine; Stavudine; Zalcitabine

Study Results

No Results Posted as of Oct 29, 2021