A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Nevirapine Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study 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 |
| Estimated Enrollment: | 217 |
| Study Completion Date: | April 2002 |
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.
Eligibility| Ages Eligible for Study: | 6 Months to 21 Years |
| Genders Eligible for Study: | Both |
| 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
Show 62 Study Locations| Study Chair: | Andrea Kovacs | |
| Study Chair: | Sandra Burchett |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000902 History of Changes |
| Other Study ID Numbers: | ACTG 366, 11329 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 30, 2012 |
| Health Authority: | United States: Federal Government |
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 Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zalcitabine Didanosine Zidovudine Stavudine |
Nevirapine Lamivudine Ritonavir Nelfinavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 23, 2013