A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients

Gilead Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: HIV Infections

Treatments: Drug: Tenofovir DF; Drug: Tenofovir alafenamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00036634

GS-120-1101

Details and patient eligibility

About

This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• HIV-1 RNA levels greater than or equal to 30,000 copies/mL
• CD4 count greater than or equal to 200 cells/mm3
• Serum creatinine <1.5 mg/dl
• Hepatic transaminases less than or equal to 2.5 times the upper limit of normal
• Total bilirubin less than or equal to 1.5 mg/dL
• Adequate hematologic function
• Serum amylase less than or equal to 1.5 times the upper limit of normal
• Serum phosphate greater than or equal to 2.2 mg/dL
• Not pregnant

Exclusion Criteria

• Prior treatment with antiretroviral therapy
• Immunization within 30 days of study entry
• A new AIDS defining condition within 30 days of study entry
• Receiving nephrotoxic agents, probenecid, chemotherapeutic agents, corticosteroids, interleukin-2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

Tenofovir DF

Active Comparator group

Description:

Participants received tenofovir DF 300 mg for 14 days

Treatment:

Drug: Tenofovir DF

Tenofovir alafenamide 50 mg

Experimental group

Description:

Participants received tenofovir alafenamide 50 mg for 14 days

Treatment:

Drug: Tenofovir alafenamide

Tenofovir alafenamide 150 mg

Experimental group

Description:

Participants received tenofovir alafenamide 150 mg for 14 days

Treatment:

Drug: Tenofovir alafenamide