Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT00040157
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥18 years of age
* Receiving a stable triple combination antiretroviral regimen including 3TC, one other NRTI and either an NNRTI or a protease inhibitor for at least 4 months (16 weeks)
* Demonstration of initial viral suppression and subsequent rebound to be defined as an initial virological drop of at least 0.5 Logs on a 3TC-containing regimen
* Plasma HIV RNA level \> 1000 and \< 30,000 copies/mL on two occasions
* Genotypically documented M184V variant of HIV RT
* Clinically stable HIV status with no AIDS-defining events
* CD4 \> 200 cells/mm3
* Basic hematologic and chemistry parameters within acceptable limits (defined in protocol)
* All women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L of b-HCG) within 72 hours prior to the start of study medication
* No active opportunistic infection requiring treatment
* Subject must be able to provide written informed consent
* Baseline laboratory values measured within 28 days of initiating study drug as follows:
* HGB≥9.0g/dl or HCT≥27% (in the absence of blood transfusions or erythropoietin treatment in the preceding two weeks
* Absolute neutrophil count≥1000 cells/mm(\^3) (in the absence of on-going G-CSF therapy
* Platelet count ≥75,000/mm(\^3)
* AST \<7.0 times the upper limit of normal
* ALT ,7.0 times the upper limit of normal
* Serum creatinine \<1.1 times the upper limit of normal
Exclusion Criteria
* Evidence of active HBV infection as demonstrated by HBsAg positivity
* Hepatitis C co-infection
* Concurrent systemic antiviral treatment
* Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.
* Alcohol abuse
* Pregnancy or breast-feeding
* Inability to tolerate oral medication
* AST \> 7.0 times the upper limit of normal
* ALT \> 7.0 times the upper limit of normal
* Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
* Use of any other drug or substance with anti-HBV activity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00040157
Study Brief:
Protocol Section:
NCT00040157