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

This study has been completed.

Sponsor:

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT00414518

First received: December 19, 2006

Last updated: January 16, 2013

Last verified: January 2013

History of Changes

Results First Received: September 6, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV Infections
Interventions:	Drug: Tenofovir disoproxil fumarate/Emtricitabine Drug: Lopinavir/Ritonavir

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Treatment Interruption	Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) 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.
CD4 T Cell Guided Therapy	Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements

Participant Flow: Overall Study

	Treatment Interruption	CD4 T Cell Guided Therapy
STARTED	7	9
COMPLETED	7	9
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Arm A	Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) 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.
Arm B	Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
Total	Total of all reporting groups

Baseline Measures

	Arm A	Arm B	Total
Number of Participants [units: participants]	7	9	16
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	7	9	16
>=65 years	0	0	0
Gender [units: participants]
Female	3	5	8
Male	4	4	8
Region of Enrollment [units: participants]
United States	3	4	7
Zimbabwe	4	5	9

Outcome Measures

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1. Primary:

Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms [ Time Frame: At Week 24 ]

Measure Type	Primary
Measure Title	Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms
Measure Description	No text entered.
Time Frame	At Week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
12 Week Treatment Arm Followed by Treatment Interruption	Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) 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.
CD4 T Cell Guided Therapyh	Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements

Measured Values

	12 Week Treatment Arm Followed by Treatment Interruption	CD4 T Cell Guided Therapyh
Number of Participants Analyzed [units: participants]	7	9
Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms [units: Log 10 copies of virus/ml] Mean ± Standard Deviation	4.8627 ± 0.9055	4.2620 ± 1.0867

No statistical analysis provided for Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms

2. Primary:

Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome [ Time Frame: At Week 24 ]

Measure Type	Primary
Measure Title	Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome
Measure Description	No text entered.
Time Frame	At Week 24
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Arm A	Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) 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.
Arm B	Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements

Measured Values

	Arm A	Arm B
Number of Participants Analyzed [units: participants]	7	9
Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome [units: participants]	1	1

No statistical analysis provided for Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome

3. Primary:

Viral Set Point [ Time Frame: Throughout study ]

Measure Type	Primary
Measure Title	Viral Set Point
Measure Description	set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus
Time Frame	Throughout study
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
12 Week Treatment Folllowed by Treatment Interruption	Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) 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.
CD4 T Cell Guided Therapy	Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements

Measured Values

	12 Week Treatment Folllowed by Treatment Interruption	CD4 T Cell Guided Therapy
Number of Participants Analyzed [units: participants]	7	9
Viral Set Point [units: Log 10 copies virus/ml] Mean ± Standard Deviation	4.8627 ± 0.9055	4.2434 ± 0.7992

No statistical analysis provided for Viral Set Point

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Michelle A. Barron
Organization: University of Colorado Denver
phone: 303-724-4939
e-mail: michelle.barron@ucdenver.edu

Publications:

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.

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.

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.

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

Gulick RM. Structured treatment interruption in patients infected with HIV: a new approach to therapy. Drugs. 2002;62(2):245-53. Review.

Responsible Party:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT00414518 History of Changes
Obsolete Identifiers:	NCT00525070, NCT01030172
Other Study ID Numbers:	06-0757, P01AI055356
Study First Received:	December 19, 2006
Results First Received:	September 6, 2012
Last Updated:	January 16, 2013
Health Authority:	United States: Federal Government

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