EUCTR2008-003917-29-GB
Active, not recruiting
Not Applicable
A Phase 1B Study of the Safety and Pharmacokinetics of Ritonavir-Boosted Elvitegravir (GS-9137/r) Plus a Background Regimen (BR) in HIV-1 Infected, Antiretroviral Treatment-Experienced Adolescents
Gilead Sciences Incorporated0 sites24 target enrollmentOctober 17, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Gilead Sciences Incorporated
- Enrollment
- 24
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- •12 years to \< 18 years of age (consent of parent or guardian required per local state or country law)
- •Subjects able to give written assent prior to any screening evaluations and willing to comply with study requirements
- •Parent or guardian able to give written informed consent prior to any screening
- •evaluations and willing to comply with study requirements
- •Body Surface Area (BSA) \= 1\.2 m2
- •Weight \= 40 kg (88 lbs)
- •Able to swallow oral tablets
- •HIV\-1 RNA \>1,000 copies/mL OR \< 400 copies/mL at screening
- •Six months of antiretroviral treatment experience or at least one documented resistance mutation as defined by current IAS\-USA Guidelines.These resistant gene mutations must be documented in a historical genotype report(s), or in the genotype/phenotype report at screening provided by Gilead Sciences.
Exclusion Criteria
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
- •A new AIDS\-defining condition diagnosed within the 30 days prior to screening (Refer to Appendix 6 of the protocol).
- •Prior treatment with any HIV\-1 integrase inhibitor
- •Females who are breastfeeding
- •Subjects receiving ongoing therapy with any medication that is not to be taken with a component of the BR, including drugs not to be taken with ritonavir (refer to prescribing information)
- •Administration of any of the medications mentioned in the protocol must be discontinued at least 30 days prior to the Baseline visit/Day 1 and for the duration of the study.
- •Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance
- •Active malignancy or treatment for active malignancy other than cutaneous Kaposi’s
- •sarcoma (KS) or basal cell carcinoma in the last two years. Subjects with biopsyconfirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and are not anticipated to require systemic therapy during the study
- •Active, serious infections (other than HIV\-1 infection) requiring parenteral (other than oral) antibiotic or anti\-fungal therapy within 30 days prior to baseline, unless agreed upon by the GSI Medical Monitor
Outcomes
Primary Outcomes
Not specified
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