A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment
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| ClinicalTrials.gov Identifier: NCT00000902 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : October 1, 2014
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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 |
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 Type : | Interventional (Clinical Trial) |
| Enrollment : | 217 participants |
| 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 : | April 2002 |
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| Ages Eligible for Study: | 6 Months to 21 Years (Child, Adult) |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000902
Show 62 Study Locations
| Study Chair: | Andrea Kovacs | ||
| Study Chair: | Sandra Burchett |
Publications of Results:
Other 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 ( Registry Identifier: DAIDS ES ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | October 1, 2014 |
| Last Verified: | October 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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Zalcitabine Didanosine Drug Therapy, Combination Zidovudine Nevirapine Stavudine |
Ritonavir Lamivudine RNA, Viral Anti-HIV Agents Nelfinavir |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Nelfinavir Lamivudine Zidovudine Nevirapine Stavudine |
Didanosine Zalcitabine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites |