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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001083 |
Purpose
For PRAM-1: To evaluate zidovudine (ZDV) + lamivudine (3TC) vs. stavudine (d4T) + ritonavir vs. ZDV + 3TC + ritonavir with respect to the change in plasma HIV-1 RNA copy number from baseline to 48 weeks [AS PER AMENDMENT 1/5/98: 72 weeks; AS PER AMENDMENT 7/17/98: 48 weeks] in stable HIV-infected children with >= 16 weeks of prior continuous antiretroviral therapy. To evaluate the safety and tolerance of ZDV + 3TC vs. d4T + ritonavir vs. ZDV + 3TC + ritonavir based upon laboratory and clinical toxicities.
AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: To evaluate d4T + nevirapine + ritonavir with respect to change in plasma HIV-1 RNA copy number from baseline to 48 weeks in children who have received at least 12 weeks of therapy on the PRAM-1 ZDV/3TC arm and have over 10,000 viral copies at weeks 12, 24, or 36. To evaluate the safety and tolerance of d4T + nevirapine + ritonavir based upon laboratory and clinical toxicities. [AS PER AMENDMENT 10/23/98: To evaluate safety and tolerance of a switch from d4T + ritonavir vs. ZDV + 3TC + ritonavir to d4T + indinavir vs. ZDV + 3TC + indinavir in stable, HIV-infected children with RNA values <= 10,000 copies/ml.] For PRAM-1: Evidence supports combination therapy with 2 or more antiviral agents as beneficial in the long-term management of HIV. The possibility exists that combination therapy may result in a synergistic or additive activity over a prolonged period of time. Also hypothesized is that the development of resistance to individual agents will be developed if viral replication is significantly decreased.
AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: Interim analysis at 12 weeks on PRAM-1 indicates that the proportion of children reaching undetectable RNA levels on the ZDV + 3TC arm is significantly less than the other two arms. The protocol, therefore, has been modified (Step 2) to permit children in the ZDV + 3TC arm with RNA copy number >= 10,000 the opportunity to change to a novel therapeutic regimen (d4T + nevirapine + ritonavir).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir Drug: Nevirapine Drug: Lamivudine Drug: Stavudine Drug: Zidovudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Primary Purpose: Treatment |
| Official Title: | A Phase II Rolling Arm Master Protocol (PRAM) of Novel Antiretroviral Therapy in Stable Experienced HIV- Infected Children; PRAM-1: ZDV+3TC vs. d4T+Ritonavir vs. ZDV+3TC+Ritonavir; PRAM-1, Step 2: d4T+Nevirapine+Ritonavir; PRAM-1, Step 3: d4T+Indinavir vs. ZDV+3TC+Indinavir |
| Estimated Enrollment: | 240 |
| Primary Completion Date: | June 2001 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 2 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2:
Prior Medication:
Required:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
[AS PER AMENDMENT 10/23/98: The following are excluded in patients receiving indinavir:
Patients with the following prior conditions and symptoms are excluded:
Prior Medication:
Excluded:
Investigational drug therapy within 2 weeks prior to randomization.
NOTE:
Contacts and Locations
Show 61 Study Locations| Study Chair: | Nachman S | |
| Study Chair: | Wiznia A |
More Information
| ClinicalTrials.gov Identifier: | NCT00001083 History of Changes |
| Other Study ID Numbers: | ACTG 338 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 1, 2011 |
| Health Authority: | United States: Federal Government |
|
HIV-1 Drug Therapy, Combination Zidovudine Nevirapine Stavudine HIV Protease Inhibitors |
Ritonavir Lamivudine Indinavir RNA, Viral Reverse Transcriptase Inhibitors Anti-HIV Agents |
|
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 Zidovudine Stavudine Nevirapine Lamivudine |
Reverse Transcriptase Inhibitors Indinavir Ritonavir Anti-HIV Agents HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Protease Inhibitors |