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Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment

NCT ID: NCT00012519

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-07-31

Brief Summary

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Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has not been approved for use in children and the doses for the combination of the two drugs has not been studied in children. The purpose of this study is to find a combination of RTV and IDV that is safe, well tolerated, and produces drug levels in the blood of children that are comparable to effective drug levels in the blood of adults. The effectiveness of the drug combination in decreasing the amount of virus in the body will also be studied. The children enrolled in this study will have high HIV viral loads despite taking anti-HIV drugs.

Detailed Description

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Combination regimens of RTV and IDV in adults offer the benefit of two potent antiretroviral agents, convenience of twice-daily dosing, unrestricted timing of meals, and fewer renal complications. There are limited, largely anecdotal data from children suggesting that initial virologic response can also be attained in children given IDV with RTV, but there are not sufficient pharmacokinetic data to define appropriate dose regimens. This study will evaluate the clinical feasibility of a combination RTV and IDV regimen for children.

Patients will be stratified on the basis of age/Tanner stage and ability to swallow intact capsules. Patients will be randomized to either Balanced Dose or Low Dose RTV treatment arms. Patients in the Balanced Dose Arm will receive RTV and IDV in approximately equal doses. The Low Dose RTV Arm will receive a dosing ratio of RTV:IDV of approximately 1:3. Patients will have scheduled study visits every 4 weeks for 6 months, then every 3 months for approximately 18 months. Study visits will consist of a medical history, physical exam, and blood and urine tests. Patients will have intensive pharmacokinetic analysis at Week 4 (or 2 weeks after a stable dose of study drugs has been reached) and Week 16. Study visits that include pharmacokinetic analysis will last 9 to 13 hours.

At each study visit, patients will be closely assessed for drug toxicity and virologic response. At the end of the study, patients with good virologic response and no evidence of toxicity may choose to enter a 48 week extension phase and continue taking the combination regimen.

Conditions

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HIV Infections

Keywords

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Dose-Response Relationship, Drug Drug Therapy, Combination HIV Protease Inhibitors Ritonavir Indinavir Anti-HIV Agents Viral Load Pharmacokinetics Treatment Experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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indinavir sulfate

Intervention Type DRUG

ritonavir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV infection
* HIV RNA levels \> 10,000 copies/ml within 30 days prior to study entry
* Anti-HIV drug therapy failure while on the same anti-HIV drugs for more than 16 weeks
* Body size above a certain limit (body surface area \> 0.48 m2)
* Acceptable methods of contraception
* Consent of parent or legal guardian

Exclusion Criteria

* Unable to determine HIV genotypic resistance
* HIV resistant to IDV or RTV at study screening
* Previously received IDV and RTV at the same time
* Need treatment with any medication prohibited by the study
* Glucocorticoids for more than 14 days at study entry
* Cancer requiring chemotherapy
* Drugs affecting the immune system, other than IVIG, within 3 months of study entry
* Certain abnormal laboratory results at study entry
* Pregnant or breast-feeding
* Unable to be followed at a PACTG center during the trial
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ellen Chadwick

Role: STUDY_CHAIR

Ram Yogev

Role: STUDY_CHAIR

Stephen Pelton

Role: STUDY_CHAIR

Elaine Abrams

Role: STUDY_CHAIR

Locations

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Howard Univ. Washington DC NICHD CRS

Washington D.C., District of Columbia, United States

Site Status

Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy

Gainesville, Florida, United States

Site Status

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, United States

Site Status

Chicago Children's CRS

Chicago, Illinois, United States

Site Status

Metropolitan Hosp. Ctr.

New York, New York, United States

Site Status

Columbia IMPAACT CRS

New York, New York, United States

Site Status

Harlem Hosp. Ctr. NY NICHD CRS

New York, New York, United States

Site Status

SUNY Upstate Med. Univ., Dept. of Peds.

Syracuse, New York, United States

Site Status

St. Jude/UTHSC CRS

Memphis, Tennessee, United States

Site Status

Texas Children's Hosp. CRS

Houston, Texas, United States

Site Status

VCU Health Systems, Dept. of Peds

Richmond, Virginia, United States

Site Status

San Juan City Hosp. PR NICHD CRS

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Saah AJ, Winchell GA, Nessly ML, Seniuk MA, Rhodes RR, Deutsch PJ. Pharmacokinetic profile and tolerability of indinavir-ritonavir combinations in healthy volunteers. Antimicrob Agents Chemother. 2001 Oct;45(10):2710-5. doi: 10.1128/AAC.45.10.2710-2715.2001.

Reference Type BACKGROUND
PMID: 11557459 (View on PubMed)

van Rossum AM, de Groot R, Hartwig NG, Weemaes CM, Head S, Burger DM. Pharmacokinetics of indinavir and low-dose ritonavir in children with HIV-1 infection. AIDS. 2000 Sep 29;14(14):2209-10. doi: 10.1097/00002030-200009290-00022. No abstract available.

Reference Type BACKGROUND
PMID: 11061667 (View on PubMed)

Chadwick EG, Rodman JH, Samson P, Fenton T, Abrams EJ, Nowak B, Pelton SI, Lavoie S, Knapp K, Bambji M, Yogev R, PACTG 1013 Team. Antiviral Activity, Tolerance and Pharmacokinetics of Indinavir with Two Doses of Ritonavir as Salvage Therapy in Children. 10th Conference on Retroviruses and Oppurtunistic Infections. Feb 2003. Abstract 875.

Reference Type BACKGROUND

Other Identifiers

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10191

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG P1013

Identifier Type: -

Identifier Source: secondary_id

PACTG P1013

Identifier Type: -

Identifier Source: secondary_id

P1013

Identifier Type: -

Identifier Source: org_study_id