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Completed

NCT Number: NCT00445146

Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Santurce, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Completion of a prior EVG+RTV treatment study without treatment-limiting toxicity.
  • Males and females of childbearing potential must agree to utilize effective contraception methods.
  • Ability to understand and sign a written informed consent form.

Exclusion criteria

  • Females who are pregnant or breastfeeding.
  • Participation in any other clinical trial without prior approval from the Sponsor.
  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study.
  • Subjects receiving ongoing therapy with contraindicated drugs.

Treatment and study plan

EVG

Drug

Elvitegravir (EVG) tablet administered orally once daily with food

Other names: Vitekta®, GS-9137

RTV

Drug

Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food

Other names: Norvir®

ARV regimen

Drug

The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval).

Primary outcomes

  1. Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event

    Time frame: Up to Week 408 plus 30 days

Secondary outcomes

  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events

    Time frame: Up to Week 408 plus 30 days

    Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.

  2. Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality

    Time frame: Up to Week 408 plus 30 days

    Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.

  3. Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality

    Time frame: Up to Week 408 plus 30 days

    A 'marked abnormality' was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline.

  4. Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

  5. Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

  6. White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

  7. Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

  8. Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

  9. Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

  10. Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

  11. HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

  12. Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

  13. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

  14. CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

    Time frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384

  15. Incidence of Mortality

    Time frame: Up to Week 408 plus 30 days

    The percentage of participants who died was summarized.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 2, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9137/r) Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Mar 8, 2007
Registry last updated
Apr 25, 2016

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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