Antiretroviral Therapy for Advanced HIV Disease in South Africa

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Michael Polis, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00342355

First received: June 19, 2006

Last updated: April 29, 2013

Last verified: April 2013

History of Changes

Results First Received: September 14, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV
Interventions:	Drug: Zidovudine Drug: Stavudine Drug: Didanosine Drug: Lamivudine Drug: Efavirenz 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
AZT+ddI+EFV	Zidovudine + Didanosine+Efavirenz
AZT + ddI + r/LPV	Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
d4T + 3TC + EFV	Stavudine + Lamivudine + Efavirenz
d4T + 3TC + r/LPV	Stavudine + Lamivudine + lopinavir/ritonavir

Participant Flow: Overall Study

	AZT+ddI+EFV	AZT + ddI + r/LPV	d4T + 3TC + EFV	d4T + 3TC + r/LPV
STARTED	444	440	444	443
COMPLETED	444	440	444	443
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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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
AZT+ddI+EFV	Zidovudine + Didanosine+Efavirenz
AZT + ddI + r/LPV	Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
d4T + 3TC + EFV	Stavudine + Lamivudine + efavirenz
d4T + 3TC + r/LPV	Stavudine + Lamivudine + lopinavir/ritonavir
Total	Total of all reporting groups

Baseline Measures

	AZT+ddI+EFV	AZT + ddI + r/LPV	d4T + 3TC + EFV	d4T + 3TC + r/LPV	Total
Overall Participants Analyzed [Units: Participants]	444	440	444	443	1771

Age [Units: Years] Mean (Standard Deviation)	35.3 (5.4)	35.3 (5.4)	35.5 (5.5)	35.6 (5.5)	35.4 (5.4)

Gender [Units: Participants]
Female	146	135	144	142	567
Male	298	305	300	301	1204

Region of Enrollment [Units: Participants]
South Africa	444	440	444	443	1771

Outcome Measures

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1. Primary:

Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens. [ Time Frame: January 2004 until March 31 2008 ]

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2. Secondary:

Serious Adverse Events [ Time Frame: January 2004 until March 31, 2008 ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	24.7 months
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
AZT+ddI+EFV	Zidovudine + Didanosine+Efavirenz
AZT + ddI + r/LPV	Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
d4T + 3TC + EFV	Stavudine + Lamivudine + efavirenz
d4T + 3TC + r/LPV	Stavudine + Lamivudine + lopinavir/ritonavir

Other Adverse Events

	AZT+ddI+EFV	AZT + ddI + r/LPV	d4T + 3TC + EFV	d4T + 3TC + r/LPV
Total, Other (not including serious) Adverse Events
# participants affected / at risk	0/444 (0.00%)	0/440 (0.00%)	0/444 (0.00%)	0/443 (0.00%)

Limitations and Caveats

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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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