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Completed

NCT Number: NCT00036634

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

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford Positive Care Program, Palo Alto, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenofovir DF

Drug

Tenofovir DF tablet administered orally once daily

Other names: Viread®

Tenofovir alafenamide

Drug

Tenofovir alafenamide tablet(s) administered orally once daily

Other names: GS-7340

Primary outcomes

  1. Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL)

    Time frame: Baseline to Week 2

    DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.

Secondary outcomes

  1. Change from baseline in HIV-1 RNA (log10 copies/mL)

    Time frame: Baseline to Week 2

  2. Change from baseline in CD4 cell count (cells/mm3)

    Time frame: Baseline to Week 2

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 1/2, Randomized, Double-Blind, Active Controlled, Dose Escalation Study of the Safety, Tolerance, Pharmacokinetic,, and Antiviral Activity of GS-7340-02 in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
May 14, 2002
Registry last updated
Jan 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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