Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection

NCT00414518 | Completed Results DMC

• 2 other identifiers: 06-0757P01AI055356
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV. This study will also compare the effects of a treatment regimen including treatment interruption with a treatment plan based on clinical indicators.

Conditions

HIV Infections

Keywords

Acute Infection; Early HIV Infection; Short-Term Antiretroviral Therapy; Treatment Interruption; Antiretroviral Drug (ARV); ART

Outcome Measures

Primary Outcomes (3)

• Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms

  At Week 24

• Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome

  At Week 24

• Viral Set Point

  set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus

  Throughout study

Study Arms (2)

Treatment interruption

EXPERIMENTAL

Oral Tenofovir disoproxil fumarate/Emtricitabine and Lopinavir/Ritonavir for 12 weeks followed by treatment interruption if CD4 count is 450 mm\^3 or higher. When CD4 count is less than 350 mm\^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.

Drug: Tenofovir disoproxil fumarate/Emtricitabine; Drug: Lopinavir/Ritonavir

CD4 T cell guided therapy

EXPERIMENTAL

Anti Retroviral Therapy initiated when AIDS-defining illness occurs or if CD4 count is confirmed at less than 350 mm\^3 at two separate, consecutive measurements

Drug: Tenofovir disoproxil fumarate/Emtricitabine; Drug: Lopinavir/Ritonavir

Interventions

Tenofovir disoproxil fumarate/Emtricitabine DRUG

300 mg Tenofovir disoproxil fumarate/ 200 mg emtricitabine tablet taken orally once daily

Also known as: TDF/FTC

CD4 T cell guided therapy; Treatment interruption

Lopinavir/Ritonavir DRUG

Three 400 mg lopinavir/ 100 mg ritonavir soft gel capsules taken orally twice daily

Also known as: LPV/RTV

CD4 T cell guided therapy; Treatment interruption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute or recent HIV-1 infection. More information about this criterion can be found in the protocol.
• CD4 count 500 cells/mm3 or greater
• No evidence of prior or current AIDS-defining illness
• No signs or symptoms of HIV infection or AIDS-defining illness that, in the opinion of the investigator, requires ART
• Willing to use acceptable forms of contraception

You may not qualify if:

• Prior treatment with any antiretroviral drug for more than 7 days
• Use of certain drugs within 21 days of study entry
• Prior receipt of investigational anti-HIV-1 vaccine
• Ongoing therapy with systemic corticosteroids, chemotherapeutic agents, nephrotoxic systemic agents, immunomodulatory treatments, or investigational agents
• Known allergy/sensitivity to study drugs or their formulations
• Current drug or alcohol use or abuse that, in the opinion of the investigator, may interfere with the study
• Serious medical or psychiatric illness that may interfere with the study
• Hepatitis B infected
• Pregnancy or breastfeeding

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

University of Zimbabwe College of Health Sciences

Harare, Zimbabwe

Location

Related Publications (5)

• Altfeld M, Rosenberg ES, Shankarappa R, Mukherjee JS, Hecht FM, Eldridge RL, Addo MM, Poon SH, Phillips MN, Robbins GK, Sax PE, Boswell S, Kahn JO, Brander C, Goulder PJ, Levy JA, Mullins JI, Walker BD. Cellular immune responses and viral diversity in individuals treated during acute and early HIV-1 infection. J Exp Med. 2001 Jan 15;193(2):169-80. doi: 10.1084/jem.193.2.169.

  PMID: 11148221 BACKGROUND

• Fidler S, Oxenius A, Brady M, Clarke J, Cropley I, Babiker A, Zhang HT, Price D, Phillips R, Weber J. Virological and immunological effects of short-course antiretroviral therapy in primary HIV infection. AIDS. 2002 Oct 18;16(15):2049-54. doi: 10.1097/00002030-200210180-00010.

  PMID: 12370504 BACKGROUND

• Coombs RW, Speck CE, Hughes JP, Lee W, Sampoleo R, Ross SO, Dragavon J, Peterson G, Hooton TM, Collier AC, Corey L, Koutsky L, Krieger JN. Association between culturable human immunodeficiency virus type 1 (HIV-1) in semen and HIV-1 RNA levels in semen and blood: evidence for compartmentalization of HIV-1 between semen and blood. J Infect Dis. 1998 Feb;177(2):320-30. doi: 10.1086/514213.

  PMID: 9466517 BACKGROUND

• Gallant JE. Current status of antiretroviral treatment interruption and intermittent therapy strategies. MedGenMed. 2002 Sep 19;4(3):19. No abstract available.

  PMID: 12466762 BACKGROUND

• Gulick RM. Structured treatment interruption in patients infected with HIV: a new approach to therapy. Drugs. 2002;62(2):245-53. doi: 10.2165/00003495-200262020-00001.

  PMID: 11817971 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Emtricitabine; Lopinavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pyrimidinones

Results Point of Contact

• Title: Michelle A. Barron
• Organization: University of Colorado Denver

michelle.barron@ucdenver.edu

303-724-4939

Study Officials

• Michelle A. Barron, MD

  Division of Infectious Disease, University of Colorado Health Sciences Center

  STUDY CHAIR

• Margaret Borok, MRCP

  Department of Medicine, University of Zimbabwe

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 21, 2006
• Study Start: January 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 20, 2013
• Results First Posted: February 20, 2013

Record last verified: 2013-01

Locations

ZI (1); US (2)