Status:
COMPLETED
Viral Dynamics and Pharmacokinetics of Abacavir and Tenofovir
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Universitywide AIDS Research Program
GlaxoSmithKline
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Once-daily nucleotide/nucleoside reverse transcriptase inhibitor (NtRTI/NRTI) combinations form the backbone of many regimens. Although efficacy data exists between tenofovir and the pyrimidine analog...
Detailed Description
The primary objectives of this study are to compare the virologic potency and pharmacology of TDF and ABC alone and in combination. Since it is not feasible or ethical to give mono or dual-therapy wit...
Eligibility Criteria
Inclusion
- HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
- Antiretroviral naïve defined as no prior therapy.
- CD4+ cell count \> than 200 cells/ mm3 determined by site clinical laboratory within 90 days of screening.
- HIV-1 RNA level \> 5000 copies/mL obtained by site clinical laboratory within 90 days of screening.
- Laboratory values obtained by screening laboratories within 30 days of entry:
- Absolute neutrophil count (ANC) ≥ 750/mm3.
- Hemoglobin ≥ 8.0 g/dL.
- Platelet count ≥ 50,000/mm3.
- Calculated creatinine clearance (CrCl) \> 50 mL/min as estimated by the
- AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 5 x ULN.
- Total bilirubin ≤ 2.5 x ULN.
- Negative serum or urine pregnancy test within 30 days of study entry.
- Karnofsky performance score ≥ 70.
- Men and women age ≥ 18 years.
- Ability and willingness of subject to give written informed consent.
Exclusion
- Any NRTI or NNRTI-associated resistance mutations as defined by the updated International AIDS Society-USA (IAS-USA) mutation list.
- Pregnancy and breast-feeding.
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Urgent need to initiate antiretroviral therapy, as determined by the patient's primary provider.
- Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 14 days prior to study entry.
- Use of any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study entry.
- Use of human growth hormone within 30 days prior to study entry.
- Initiation of testosterone or anabolic steroids within 30 days prior to study entry. (Exception: Chronic replacement dosages in patient's with diagnosed hypogonadism is allowed)
Key Trial Info
Start Date :
December 7 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00214890
Start Date
December 7 2004
End Date
April 27 2010
Last Update
September 24 2021
Active Locations (5)
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1
UCI
Irvine, California, United States, 92668
2
USC
Los Angeles, California, United States, 90033
3
University of California San Diego
San Diego, California, United States, 92103
4
Santa Clara Valley Medical Center
San Jose, California, United States, 95128