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OpenTrials
Completed

NCT Number: NCT00004578

ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects

To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pacific Oaks Research, Beverly Hills, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV-1 positive
  • antiretroviral-adult males
  • non-pregnant
  • non-lactating females at least 18-years old with plasma HIV-1 RNA > 5000 copies/mL, who were not acutely ill

Exclusion criteria

  • History of:
  • prior antiretroviral therapy
  • significant drug hypersensitivity
  • psychiatric illness that precludes compliance
  • an active substance abuser
  • positive test results for drug abuse
  • abnormal lab test results (hemoglobin, absolute neutrophil count, platelet count, SGPT/AST or SGPT/ALT, creatinine, fasting triglycerides, significant abnormal ECG results
  • pregnancy or lactating female
  • received another investigational drug within 28 days of study initiation
  • unlikely to comply or unsuitable candidate in the opinion of the investigator

Treatment and study plan

Lopinavir/ritonavir

Drug

Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs

Other names: ABT-387, Kaletra

Lamivudine

Drug

150 mg, every 12 hours

Stavudine

Drug

40 mg every 12 hours

Primary outcomes

  1. Proportion of subjects with viral load below the limit of quantitation

    Time frame: 24 weeks

  2. Time to loss of virologic response

    Time frame: 48 weeks

Secondary outcomes

  1. Proportion of subjects with viral load below the limit of quantitation at each visit

    Time frame: At each visit

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients

Important dates

Study start
1997
Primary completion
2005
Study completion
2005
First posted
Aug 31, 2001
Registry last updated
Apr 3, 2008

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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