Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2)

NCT00371592 | Completed Phase 2 DMC

• 3 other identifiers: CIPRA PE 003CIPRA Peru Project 110413
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether acyclovir is effective in suppressing HIV viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are starting HIV treatment for the first time.

Conditions

HIV Infections; Herpesvirus 2, Human

Keywords

Treatment Naive

Outcome Measures

Primary Outcomes (1)

• Undetectable HIV plasma RNA viral load (less than 50 copies/ml)

  At Week 6

Secondary Outcomes (4)

• Undetectable HIV plasma RNA viral load (less than 50 copies/ml)

  At Week 24

• Time to undetectable HIV plasma RNA viral load (less than 50 copies/ml), adjusted for baseline viral load

  Throughout study

• Intermittent episodes of detectable HIV plasma RNA viral load (greater than 200 copies/ml)

  At Weeks 2 and 24

• Positive HIV PCR test on vaginal mucosal samples

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

Participants will receive acyclovir for 24 weeks

Drug: Acyclovir

2

PLACEBO COMPARATOR

Participants will receive acyclovir placebo for 24 weeks

Drug: Acyclovir placebo

Interventions

Acyclovir DRUG

800 mg tablet taken orally twice daily

Also known as: Zovirax

1

Acyclovir placebo DRUG

800 mg placebo tablet taken orally twice daily

Also known as: Zovirax placebo

2

Eligibility Criteria

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

You may qualify if:

• HIV-1 infected
• HSV-2 infected
• Initiating HAART per Peruvian guidelines for the first time at study entry
• CD4 count less than 200 cells/mm3 OR CD4 count less than 350 cells/mm3 AND viral load greater than 55,000 copies/ml within 30 days prior to study entry
• Does not intend to move outside of greater metropolitan Lima, Peru area for the duration of the study
• Willing to follow all study requirements
• Willing to provide written informed consent

You may not qualify if:

• Prior HAART
• History of adverse reaction to acyclovir, famciclovir, or valacyclovir
• Unwilling to take acyclovir, famciclovir, or valacyclovir
• History of seizures
• Renal insufficiency, defined as serum creatinine greater than 2 mg/dl or a creatinine clearance less than 50 ml/min
• Treatment for a serious medical condition 14 days prior to study entry. Patients with chronic, acute, or recurrent opportunistic infections (OIs) who have completed therapy and are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
• Clinically unstable and untreated OIs or tumors within 14 days prior to study entry. More information on this criterion can be found in the protocol.
• Clinically unstable and untreated bacterial sexually transmitted diseases (STDs) within 14 days prior to study entry. More information on this criterion can be found in the protocol.
• Radiation therapy or systemic chemotherapy within 45 days prior to study entry. Participants who underwent systemic chemotherapy for the treatment of Kaposi's sarcoma (KS) if it was completed prior to study entry are not excluded.
• Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry. Patients who received a tapering course of corticosteroids as acute therapy for Pneumocystis carinii pneumonia (PCP) or are receiving inhaled or nasal fluticasone are not excluded.
• Current drug or alcohol use that, in the investigator's opinion, may interfere with the study
• Vomiting or inability to swallow medications
• Involuntarily incarcerated in a correctional facility, prison, or jail or being detained for the treatment of either a psychiatric or infectious disease
• Grade 2 or 3 high-grade cervical dysplasia and cervical neoplasia within 6 months prior to study entry
• Any other condition that, in the investigator's opinion, may interfere with the study

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Comprehensive International Program of Research on AIDS: collaborator

Study Sites (1)

IMPACTA - San Miguel CIPRA Project 1 CRS

San Miguel, Lima region, 32, Peru

Location

Related Publications (3)

• Posavad CM, Wald A, Kuntz S, Huang ML, Selke S, Krantz E, Corey L. Frequent reactivation of herpes simplex virus among HIV-1-infected patients treated with highly active antiretroviral therapy. J Infect Dis. 2004 Aug 15;190(4):693-6. doi: 10.1086/422755. Epub 2004 Jul 13.

  PMID: 15272395 BACKGROUND

• Wright PW, Hoesley CJ, Squires KE, Croom-Rivers A, Weiss HL, Gnann JW Jr. A prospective study of genital herpes simplex virus type 2 infection in human immunodeficiency virus type 1 (HIV-1)-seropositive women: correlations with CD4 cell count and plasma HIV-1 RNA level. Clin Infect Dis. 2003 Jan 15;36(2):207-11. doi: 10.1086/345440. Epub 2003 Jan 6.

  PMID: 12522754 BACKGROUND

• Schacker T, Zeh J, Hu H, Shaughnessy M, Corey L. Changes in plasma human immunodeficiency virus type 1 RNA associated with herpes simplex virus reactivation and suppression. J Infect Dis. 2002 Dec 15;186(12):1718-25. doi: 10.1086/345771. Epub 2002 Nov 22.

  PMID: 12447756 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Acyclovir

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)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Aldo Lucchetti, MD

  Asociación Civil Impacta Salud y Educación, Lima, Peru

  STUDY CHAIR

• Connie Celum, MD, MPH

  University of Washington

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2006
• First Posted: September 4, 2006
• Study Start: September 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

PE (1)